Director, Biostatistics

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005.

SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Directs departmental activities and maintains the statistical integrity of clinical trials analyzed by SDC. Leads efforts in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Oversees departmental resources and budgets. Mentors and trains team members in their roles, emphasizing quality.

Primary Responsibilities

·        Manage statistical and statistical programming activities involved in the design, analysis and interpretation of clinical trials data conducted by SDC.

·        Supervise and direct staff, both permanent and temporary, to include assignment of work, allocation of statistical resources and management of timelines to ensure contractual obligations and objectives are met.

•       Serve as a consultant with internal and external cross-functional areas regarding statistical operations.

•       Function in the role as Senior Biostatistician on clinical trial(s) as required.

·        Functions as a senior reviewing statistician, responsible for the timeliness and quality of departmental deliverables.

·        Assess operational needs and requirements; ensure efficient allocation of resources and adequate staffing to meet goals and objectives of the department.

·        Contribute to the development of standard operating procedures for clinical trials; ensure that statisticians and statistical programmers appropriately interpret and follow procedures.

·        Prepare reports that summarize the analysis of data, interpret findings and provide conclusions and recommendations.

·        Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings.

•       Adheres to all aspects of the SDC’s quality system.

•       Complies with SDC’s data integrity & business ethics requirements.

•       Perform other related duties incidental to the work described herein.

•       Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

•       Successful record of accomplishment in establishing, directing and overseeing statistical operations division/department.

•       Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11.

•       Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills.

•       Excellent analytical skills, with the ability to process scientific and medical data.

•       Excellent knowledge of statistical programming.

•       Ability to identify data issues, present problems, and implement solutions.

•       Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues.

•       Good leadership, organizational and time management skills, with the ability to multi-task.

•       Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines

•       (FDA/CFR, ICH/GCP).

•       Strong interpersonal communication and presentation skills.

•       Focus on quality at all times and in all situations.

•       Ability to work in stressful situations and with challenging people.

•       Strong teaching and mentoring skills.

Education or Equivalent Experience

Typically a Master’s degree in biostatistics, statistics or other related, scientific field and nine years of relevant professional experience to include supervision and management experience; or equivalent combination of experience, education, and/or demonstrated ability.

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

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Interactive Response Technologies - Project Manager

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005.

SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Oversees and coordinates all lRT activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout. Manages the day-to-day IRT project activities including, but not limited to, timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains IRT Programmer on IRT build requirements

Primary Responsibilities

·        Lead IRT study setup activities including IRT design and specification (with edit checks) documents and approval and user acceptance testing.

·        Allocate and prioritize workloads for multiple projects

·        Serve as primary client contact for IRT

·        Work with Clinical Data Managers and Statistical Leads with management of timelines and budgets as they pertain to IRT activities

·        Work with study team to reconcile IRT data with clinical data and oversees data transfers

·        Mentor IRT Programmer on IRT build requirements

·        Develop documentation for validation and maintenance of IRT databases for clinical trials using a variety of validated software applications

·        Maintains quality control of the data, project deliverables and closeouts

·        Adhere to all aspects of the SDC's quality system

·        Comply with SDC's data integrity & business ethics requirements

·        Develop and maintain SOPs and tools relating to the IRT

·        Perform other related duties incidental to the work described herein

·        Adherence to all essential systems and processes that are required at SOC to maintain compliance to business and regulatory requirements 

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

·        Exceptional working knowledge of clinical trials and IRT role in the clinical trials process

·        A minimum of 1 year of staff mentoring and leadership experience

·        Strong leadership capabilities

·        Strong delegation abilities

·        Highly effective communication skills, both written and verbal

·        Ability to work as a member of a multi-disciplinary team and adapt to changing priorities

·        Training and experience in clinical database management

·        General knowledge of GCPs and the conduct of clinical trials.

·        Understanding of the clinical research process flow and drug development processes.

·        Understanding of software development and testing processes.

·        Demonstrated proficiency in office productivity applications (e.g., Microsoft Word, PowerPoint, and Excel).

·        Excellent organizational skills

·        Ability to manage multiple tasks simultaneously and to prioritize tasks effectively.

·        Demonstrated ability to focus on project work and efficiently bring projects to completion

·        Ability to effectively manage projects, budgets and timelines

·       Ability to learn new systems without formal training

Education or Equivalent Experience

Bachelor's degree in engineering, applied or life science and at least two (2) years of experience in management of an IRT system or an Associate's degree in engineering, applied or life science and a minimum of five (5) years of experience in management of an IRT system.

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid

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Senior Clinical Programmer

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

Job Summary

Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Works with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. Develops data entry screens and programs, and data quality edit checks to comply with related specifications. Accomplishes database structure testing. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Actively promotes standards for the development and acquisition of systems. Communicates with the end-users. Mentors/trains junior level clinical programmers.

Primary Responsibilities

·       Assist in developing, validating, and maintaining clinical databases for clinical trials using a variety of validated software applications

·       Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans

•       Build and validate data entry screens (paper and/or electronic data capture (EDC))

•       Implement and test data quality checks in accordance with the study data validation manual

·       Assist in developing and maintaining global library of clinical database forms, edit checks, and other regularly used programs and routines

•       Utilize copies of like database elements from library structures or other similar studies during builds

•       Batch load external data from vendors (e.g., central lab data)

•       Participate in internal and external team meetings, as necessary

•       Assist in management of user access to clinical databases

·       Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug

•       Participate in writing departmental documentation (e.g., training documents, process guidances)

•       Participate in other clinical programming and data management activities, as required

•       Mentor junior level clinical programmers

•       Adhere to all aspects of the Statistics & Data Corporation’s quality system

•       Comply with Statistics & Data Corporation’s data integrity & business ethics requirements

•       Perform other related duties incidental to the work described herein

·       Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

•       At least six years’ experience assuming lead database programming responsibilities on projects, with a minimum of 3 years in a clinical environment

•       Excellent understanding of relational database structures

•       Fast, accurate programming skills using assorted application software

•       PL/SQL, SQL, and XML programming skills

•       Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships

•       Demonstrated ability to provide both “user-friendly” and technical documentation

•       Ability to provide expertise to guide department in continued efficiency and growth

•       Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP)

•       Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment

•       C#, C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge /experience not required, but desirable

•       Medidata Rave and iMedNet EDC knowledge / experience not required, but desirable

•       Reporting application development (e.g. JReview, Business Objects, Spotfire) knowledge / experience not required, but desirable

Education or Equivalent Experience

•       Bachelor’s degree in computer science or other quantitative or scientific discipline with 6+ years’ experience in database programming and demonstrated working knowledge of scientific principles.

•       Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree

Why SDC

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid

See more jobs at Statistics & Current Openings

Apply for this job

Manager, Clinical Data Management

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop   great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own   and delivering exceptional results. We are a specialty CRO   in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry.

Job Summary

Oversees and manages all aspects of Data Management Operations including staffing and resourcing, project management, operations management and client management. Applies a high level of technical expertise to effectively lead all Data Management tasks.

Job Location:MA/NC (Hybrid)

Primary Responsibilities

•         Oversees day-to-day data management operations, ensuring on-time and quality deliverables and excellent client service and satisfaction

•         Manages one or more key accounts and studies; interfaces with the client to address feedback, ensure risks and issues are resolved 

•         Serves as subject matter expert during client and vendor meetings

•         Leads teams located globally (Hyderabad locations) to deliver all aspects in Data Management including the Database build processes

•         Performs independent review or quality review of all team deliverables prior to sending to client

•         Performs all client communications across the DM functions; face to face, teleconferences and emails for lead role tasks.

•         Performs internal escalations, project status updates and project management functions including updates to PM systems

•         Actively supports business development in capabilities presentations to prospective and current clients

•         Effectively provides input for department and clinical study budgets

•         Liaises with internal and external cross-functional teams, sponsors, vendors, etc.

•         Serves as Project Manager on clinical studies, as needed

•         Works closely with Director of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff

•         Ensures project work is planned, resource allocated and is successfully executed

•         Provides direction to staff when issues arise that the staff cannot resolve on their own

•         Ensures proper training and development of staff

•         Conducts regular meetings, actively manages performance and completes year-end performance reviews with all direct reports

•         Monitors performance of team and initiates process and resource improvement in partnership with Director of Data Management

•         Adheres to all aspects of the company’s quality system

•         Complies with the company’s data integrity and business ethics requirements

•         Performs other related duties incidental to the work described herein

•         Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

•         Articulate and professional

•         Extensive experience in clinical research and Data Management in multiple therapeutic areas

•         Electronic Data Capturing (EDC) RAVE experience

•         Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations

•         Strong project management abilities including analytical evaluation, organization, delegation, flexible team

•         management, negotiating and resource management skills

•         Effective leadership, budget forecast and implementation skills

•         May Require Travel up to 20%

Education or Equivalent Experience

·         Master’s degree (preferably in Engineering, Applied or Life Science) and at least three (3) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree (preferably in Engineering, Applied or Life Science) with a minimum of five (5) years in DM

·         One  year of experience direct management of personnel

·         Clinical research in a CRO setting is preferred.

Why SDC

•             We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

•             We are passionate about our company culture. Our recognition program is  directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. 

•             We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

•             We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

•             With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid​

See more jobs at Statistics & Current Openings

Apply for this job

Manager, Data Insights & Automation

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

Job Summary

Lead and manage the effort to clean, process, store and analyze clinical data with its application towards research and development of Artificial Intelligence (AI) and Machine Learning (ML) algorithms supporting better understanding of the safety and efficacy of new therapies. Contribute to the organization’s strong drive to be at forefront of using AI in clinical trials to simplify data processing and discover imperceptible correlations. 

Lead and manage software development activities to drive automation across SDC departments reducing error and increasing efficiency across those departments.  Serve as the primary point within the company driving standardization.

Primary Responsibilities

·        Oversees day to data activities involving custom software, data engineering and automation.

·        Develop standard metrics demonstrating model performance, robustness, and validity.

·        Engage with various internal departments such as data management, technology solutions, biostatistics, IT, and business development to strategically identify areas to develop automations, apply AI and/or ML toward increasing the efficiency of processes and detecting information trends.

·        Ensure that algorithms can be practically deployed with minimal resource usage and maximum ease of use in existing architecture.

·        Deliver high quality software design documentation

·        Prototype new ideas/technologies to create proof of concept and demos

·        Contribute to the development of standard operating procedures for the use of artificial intelligence within clinical trials.

·        Perform other related duties incidental to the work described herein.

·        Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

·        Fluency in Python with experience parsing, manipulating, and converting data to and from a wide range of formats (CSV, json, XML, html, SQL tables, etc.)

·        Experience in designing and deploying production applications.

·        System design capabilities to improve operational efficiency and costs.

·        Experience in the software development lifecycle.

·        Experience mentoring and managing other team members.

·        Experience in writing and implementing policy and procedures.

·        Ability to work with stakeholders to translate business requirements into clear technical specifications.

·        Ability to communicate effectively in writing and verbally.

·        Ability to identify issues, present problems, and implement solutions.

·        Capability of communicating technical concepts clearly, concisely, and understandably to non-technical colleagues

·        Good leadership, organizational and time management skills, with the ability to multi-task

Strong interpersonal communication and presentation skills

Education or Equivalent Experience

A Master’s degree in statistics, engineering, operations research, mathematics, computer science, business analytics or other related field, with focus in artificial intelligence preferred, and at least 5+ years of relevant professional experience or a bachelor’s degree with 7+ years of relevant professional experience

Why SDC

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid​

See more jobs at Statistics & Current Openings

Apply for this job

Software Developer (Python & Backend)

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

Job Summary:

The Software Developer will develop and maintain business process automation(s) to automate steps within the CRO operations lifecycle. This includes acting on local flat files, integrating with APIs as well as operating with databases. The role contributes to the organization’s strong drive to be at the forefront of using Artificial Intelligence (AI) in clinical trials to simplify data processing and discover imperceptible correlations.

Primary Responsibilities

• Develops and maintains existing automation applications using test driven development

• Assists in the design of new applications

• Maintain Azure based cloud-based resources

• Engages with various internal cross-functional departments to develop and implement software applications while understanding the underlying data

• Delivers high quality software test and code documentation

• Contributes to the development of standard operating procedures for the use of artificial intelligence and software development within clinical trials

• Prototypes new ideas/technologies to create proof of concept and demos

• Provides mentorship for associate software developers

• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

• Act as a resource for other team members for debugging, code reviews and other software development lifecycle activities

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

• Fluent in Java Script and Proficient in Python.

• Experience with REST APIs

• Experience in the software development lifecycle.

• Ability to work with stakeholders to translate business requirements into clear technical specifications

• Ability to communicate effectively in writing and verbally.

• Ability to identify issues, present problems, and implement solutions

• Capability of communicating technical concepts clearly, concisely, and understandably to non-technical colleagues

• Good organizational and time management skills, with the ability to push forward multiple projects simultaneously

• Strong interpersonal communication and presentation skills

Education or Equivalent Experience

• Bachelor’s degree in a technical field with 4 years of technical experience with the last 2 years being a Software Development centric role

OR

• 6+ years in a technical role with the last 2 years being a Software Development centric role

Why SDC

We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

See more jobs at Statistics & Current Openings

Apply for this job

Technology Implementation Manager

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

Job Summary:

• Manages technology implementations within the company in collaboration with partners and sponsors, as applicable. Manages the SDLC including but not limited to the development and maintenance of the required systems, infrastructure considerations, and personnel associated with each technology project. This position will ensure both SDC-built applications and dashboards have appropriate validation documentation in place according to standard operating procedures. Works closely with all functional areas, SMEs, and stakeholders to ensure complete and accurate user requirements and successful interactions throughout each stage. This position ensures the project is delivered successfully and according to five key project management stages (Define, Plan, Execute (monitor and adjust), Complete, and Evaluate). The role contributes to the organization’s strong drive to be at the forefront of using Artificial Intelligence (AI) in clinical trials to simplify data processing and discover imperceptible correlations.

Primary Responsibilities

• Direct day-to-day assigned technology project activities, including scoping, evaluation, ROI, planning, timeline, percent complete, cost, time recorded, and SDLC tasks.
• Maintain assigned technology project plans, including estimated resourcing requirements for each project and across all assigned projects.
• Engage with various internal departments such as Data Management, Technology Solutions, Biostatistics, Statistical Programming, Project Management, IT, and Business Development to strategically align technology implementation product roadmap to business needs and strategy.
• Work with SDC executives to prioritize planned and unplanned technology implementation and maintenance of assigned projects.
• Serve as the primary point of contact on assigned technology projects and share project status, constraints and implementation solutions with SDC executives and other partner organizations, based on project details.
• Collaborate with technical and non-technical team members to ensure business needs are defined and understood and the technology implemented meets the needs and expectation of the business.
• Assess and implement systems according to a risk-based validation strategy and ensure alignment with QMS team.
• Define, with stakeholder input, technology solution onboarding and transition activities to ensure successful utilization of solution through business and/or end user adoption, including stakeholder trainings, departmental implementation plans, marketing and sales support.
• Proactively manage, communicate, and escalate risk to executives and applicable stakeholders, ensuring successful project implementation on-time and within budget.
• Develop or assist with key SDLC validation tasks to ensure project success.
• Lead key initiatives within the organization and across functions.
• Perform other related duties incidental to the work described herein.
• Adhere to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements. 

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

• Comprehensive understanding of product development pertaining to clinical trial technologies, project management, client service, contracts and amendments, and key business systems
• Solid technology background in key areas of the business;  wearable devices, device integrations, system integrations, GCP Biometric systems, etc.
• Good computer skills to include strong knowledge of MS Office suite of software and/or other project management software
• Successful record of accomplishment in managing a high performing team and managing without authority across functions
• Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
• Comprehensive understanding of FDA Computer System Validation requirements and agile software development life cycles
• Skilled in client service, conflict resolution, delegation, flexible team management, negotiating and resource management skills
• Ability to identify issues, and present and implement solutions efficiently and effectively
• Capability of communicating complex concepts clearly, concisely, and understandably to non-expert colleagues
• Advanced leadership, organizational and time management skills, with the ability to multi-task
• Strong interpersonal communication and presentation skills
• Able to lead a team of technical and non-technical employees to ensure project success
• Ability to develop and deliver presentations
• Ability to communicate effectively in writing and verbally
• Continuous learner with a good understanding of new GxP technology trends and ability to promote innovative solutions.

Education or Equivalent Experience

A Master’s degree in information and data science, operations research, mathematics, statistics, computer science or other related field, with focus in software development preferred, and at least eight (8) years of relevant professional experience or a Bachelor degree with ten (10) years of relevant professional experience

Why SDC

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid​

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Senior Quality Assurance Specialist - Validation

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

Job Summary

Provides oversight of SDC’s quality management system (QMS) and notifies management of issues. Actively participates in collecting and reporting quality metric data and provides related input to leadership as required. Conducts detailed inquiries into quality related issues to propose appropriate corrective actions and lessons learned. Analyzes quality KPIs (Key Performance Indicators) for trends and improvement opportunities. Serves as the senior quality lead on internal validation projects and manages the supplier qualification program, performing audits as needed. Mentors quality and other SDC personnel as needed.

Primary Responsibilities

• Serves as the QA lead on validation projects, which includes providing validation guidance to teams as well as reviewing and approving all validation documentation (Validation Plans, Specifications, Executed Scripts, Validation Summary Reports, Change Controls).

• Manages the supplier qualification program; ensures compliance with current process, and suggests improvements to the program as needed.

• Conducts internal and external (supplier) audits as needed.

• Assists with data collection, trending, and reporting of Quality KPI metrics.

• Identifies areas of quality deficiency ensuring escalation to leadership and communication with appropriate staff.

• Acts as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as required.

• Creates and revises documentation as needed (SOPs, Policies, Work Instructions).

• Mentors quality and SDC personnel as needed.

• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

• Thorough understanding and application of validation and software development lifecycle, including Good Automated Manufacturing Practice (GAMP) guideline.

• Ability to work independently on various projects while also mentoring staff.

• Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.

• Thorough knowledge, understanding, and application of ICH Guidelines for Good Clinical Practice, Annex 11, and Title 21 of the Code of Federal Regulations, including 21CFRPart11.

• Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc.

• Excellent verbal and written communication skills

• Excellent collaboration skills

• Ability to multitask in a very fast paced environment with multiple priorities

Education or Equivalent Experience

• Typically a Bachelor’s degree in applied or life science or engineering with advanced degree preferred or equivalent education and experience.

• Typically 5+ years of experience is preferred in Quality within the pharmaceutical/CRO industry or equivalent combination of experience, education and/or demonstrated ability.

• Previous experience managing and performing audits is required.

Why SDC

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid​

See more jobs at Statistics & Current Openings

Apply for this job

Manager, Clinical Data Management

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop   great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own   and delivering exceptional results. We are a specialty CRO   in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry.

Job Summary

Oversees and manages all aspects of Data Management Operations including staffing and resourcing, project management, operations management and client management. Applies a high level of technical expertise to effectively lead all Data Management tasks.

Primary Responsibilities

•       Oversees day-to-day data management operations

•       Serves as subject matter expert during client and vendor meetings

•       Actively supports business development in capabilities presentations to prospective and current clients

•       Effectively provides input for department and clinical study budgets

•       Liaises with internal and external cross-functional teams, sponsors, vendors, etc.

•       Serves as Project Manager on clinical studies, as needed

•       Works closely with Director of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff

•       Ensures project work is planned, resource allocated and is successfully executed

•       Provides direction to staff when issues arise that the staff cannot resolve on their own

•       Ensures proper training and development of staff

•       Conducts regular meetings and completes year-end performance reviews with all direct reports

•       Monitors performance of team and initiates process and resource improvement in partnership with Director of Data Management

•       Adheres to all aspects of the company’s quality system

•       Complies with the company’s data integrity and business ethics requirements

•       Performs other related duties incidental to the work described herein

•       Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

• Articulate and professional

• Extensive experience in Clinical research and Data Management in multiple therapeutic areas

• Electronic Data Capturing (EDC) experience; experience utilizing Medidata Rave a strong plus

• Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of

• Federal Regulations

• Strong project management abilities including analytical evaluation, organization, delegation, flexible team

• management, negotiating and resource management skills

• Effective leadership, budget forecast and implementation skills

• May Require Travel up to 20%

Education or Equivalent Experience

• Master’s degree (preferably in Engineering, Applied or Life Science) and at least five (5) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree (preferably in Engineering, Applied or Life Science) or equivalent education and work experience with a minimum of six (6) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial.

• Two (2) years of experience direct management of personnel is preferred.

• Clinical research in a CRO setting and CDISC SDTM training is preferred.

Why SDC

•             We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

•             We are passionate about our company culture. Our recognition program is  directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. 

•             We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

•             We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

•             With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid​

See more jobs at Statistics & Current Openings

Apply for this job