Senior Clinical Programmer (RAVE EDC)

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

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

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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Business Operations Associate

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

Business Operations Associate responsibilities include working with Business Development, Accounting, Quality Assurance, Operations, External Vendors, Partners, and Sponsors to draft requests for information (RFI) proposals with associated pricing, Work Orders (WO), and Work Order Amendments (WOA) that are responsive to Partner/Sponsor needs.  Communicate the status of WO and WOAs internally and with external Partners/Sponsors as appropriate. This work needs to be accomplished in a very timely, professional manner that indicates great attention to detail. Upon execution (signature) of WO and WOAs, ensure that Accounting receives the original copy, and a hand-off meeting is scheduled with Operations.     

Primary Responsibilities

·        Prepare the High Probability Billing Milestone forecast and share with Business Development and Accounting.

·        Align with Accounting on New Authorization amounts.

·        Review and update (if needed) draft RFIs, pricing, proposals, WO and WOAs with Manager, Business Operations and support the presentation and updates (if needed) during leadership review.

·        Ensure quality check is performed on all Business Operations deliverables prior to sending.

·        Deliver approved RFI, pricing, proposals, WO and WOAs to Business Development and/or external Partners/Sponsors.

·        Ensure that all RFIs, proposals, contracts and associated documents are saved and maintained via Business Operations drives and systems.

·        Ensure that required information from RFIs contracts, proposals, etc. s are updated and maintained in Client Service Management System (Salesforce).

·        Support project activation activities in the project management and finance systems.

·        Maintain complete cognizance of contractual requirements and support project managers and finance with the successful execution of projects.

·        Monitor project scope checkpoints to identify scope creep as early as possible and support initiation of WOA process.

·        Support project managers and finance with each step of the contract amendment lifecycle.

·        Support project managers and finance with ongoing management of project and financial information within the Enterprise Resource Planning (ERP) platform and other financial reports.

·        Work with project management and finance to report analyzed data for projects and communicate results.

·        Escalate any risks or issues to Manager of Business Operations

·        Coordinate and work with external vendors on new service contracts and scope management/change orders for existing contracts. Manage external vendor contract execution process for contracted projects.

·        Support continuous improvement initiatives spearheaded by executive management and/or department heads

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

·        Perform other duties as assigned.

·        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

·        Exceptional customer support skills

·        Exceptional organization and planning skills

·        Excellent prioritization and time management abilities

·        Exceptional quality and on time delivery

Excellent understanding of contracts and contract amendment lifecycle and demonstrated ability to manage contracts and amendments

·        Good analytical and problem-solving skills to include excellent ability to identify and resolve problems early

·        Solid independent, critical thinking ability and demonstrated ability to work autonomously with minimum supervision

·        Keen ability to accurately discern priorities in a resource constrained work environment

·        Solid understanding of SDC service and technology offerings and processes

·        Excellent verbal and written communication skills

·        Excellent computer skills to include strong knowledge and MS Office suite of software

·        Strong knowledge of Client Relationship Management System – Salesforce

·        Familiarity with ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.

Education or Equivalent Experience

·        A Bachelor’s degree, preferably in engineering, applied or life sciences or business is required. 

·        Two years of experience in business development, account management, contracts management, project or purchasing in the clinical trial industry is preferred. 

·        Salesforce Certified Advanced Administrator is required.

·        Salesforce Certified Platform App Builder is recommended.

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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HR Specialist/Accountant 

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

The HR Specialist/Accountant is responsible for a variety of administrative and Human Resources activities including assisting with tasks from initial onboarding to offboarding of employees and accounting tasks. The HR Specialist/Accountant must be prepared to work independently in the functional areas of HR and Accounting. This role will help evaluate and administer policies, programs, and procedures within HR that are aligned with the overall business strategy and provide support to the Accounting team in carrying out the responsibilities of the Finance / Accounting Department.

Primary Responsibilities

·        Ensure company adherence to human resources practices and procedures

·        Act as an employee resource for human resource topics, escalating concerns or grievances as needed

·        Facilitate new hire orientation and onboarding, including working with hiring teams on onboarding schedules

·        Ensure data integrity within HRIS for employee changes, leaves of absence, and time off use

·        Assist with payroll processes, statutory compliances, and related employee changes

·        Work with partners and providers to assist employees in resolving benefit related issues

·        Complete external requests for employment verifications

·        Assist with employee exit procedures; may include exit interviews

·        May assist with administration and tracking of performance management, benefits enrollment, goal setting, time off balances, and training

·        Work on special projects, team initiatives and other tasks as assigned

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

·        Support Accounts payable and Accounts receivable functions

·        Assist with timely and accurate month-end reporting, account analysis, reconciliations and schedules, and fixed asset accounting

·        Work with GL accounts and journal entries

·        Multi-entity accounting functions

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

·        Ability to maintain the highly confidential nature of human resources work, including personal information and compensation

·        Understanding of regional/local HR and employment requirements

·        Excellent verbal and written communication and presentation skills

·        Excellent computer skills in a Microsoft Windows environment

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

·        Capability of communicating concepts clearly, concisely, and understandably to various levels of colleagues

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

·        Knowledge of finance, accounting, budgeting, and cost control principles including Generally Accepted Accounting Principles.

·        Proficient in MS Excel. (VLOOKUP and Pivot tables)

Education or Equivalent Experience

·        A bachelor's degree in finance, accounting, business, human resources, or communications and 2 years of relevant HR/Accounting experience is required.

·        HR certification is preferred

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

See more jobs at Statistics & Current Openings

Apply for this job

Software Developer (JavaScript & Frontend)

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:

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

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!

See more jobs at Statistics & Current Openings

Apply for this job

Analytics Engineer

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

The Analytics engineer is a modern data team member that is responsible for modeling data to provide clean, accurate datasets. These datasets will feed data visualizations and reports for different users within the company. The role entails transforming, testing, and documenting data. 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

·        Models raw data into clean, tested, and reusable datasets to make it easier for business analysts and other stakeholders to view and understand data in a data warehouse or database.

·        Maintains data documentation to ensure that everyone on the team uses the same definitions and language.

·        This involves providing identifiable and understandable descriptions of data as well as exposing them in a way for all consumers to easily find answers to their queries.

·        Defines certain metrics to be used and measures to be taken to guarantee data is accurate enough to fit operational and analytics needs.

·        Works closely with Data Analysts and Business Intelligence Analysts to create tables and views that improve the dashboard performance and simplify build process.

·        Builds dashboards, graphs, charts, and reports using BI tools.

·        Follows Data Quality, Data Governance and Master Data Management Best Practices to enable the business to maintain clean and accurate data.

·        Engages with various internal cross-functional departments to develop and implement data tables, views, and metrics.

·        Delivers high quality software tests and code documentation.

·        Contributes to the development of standard operating procedures for the use of artificial intelligence and data engineering within clinical trials.

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

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

·        Acts 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

• Fluency in SQL and parsing, manipulating, and converting data into tables and views.

• Familiarity with python data libraries (e.g., pandas, dbt).

• Ability to work with database management tools (e.g., dbeaver, datagrip).

• Ability to do use git to handle version control.

• An understanding of modern RDBMS concepts (joins, indexes, views) and SQL syntax (group by, having), including experience with at least one modern RDBMS.

• 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 2 years of technical experience with the last 2 years of SQL related experience being a Data Engineering centric role OR 3+ years in a technical role with the last 2 years being an Analytics centric role.

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

See more jobs at Statistics & Current Openings

Apply for this job

Principal Medical Coding Specialist

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

Manages the medical coding activities for multiple projects, including coding of clinical terms, dictionary subscription management and selection, validation, implementation and management of coding systems. Ensures medical coding practices are in compliance with US and OUS regulatory requirements. Responsible for training, mentoring staff on medical coding practices Ensures coding is performed accurately and consistently by other medical coding staff.

Primary Responsibilities

• Author and revise SDC medical coding SOPs and Work Instructions as needed to ensure they are in compliance of regulatory requirements

• Serve as a subject matter expert on use of medical dictionaries and coding practices to project team and clients

• Provide guidance to clients on medical dictionary subscription requirements

• Manage dictionary subscriptions versions for current projects

• Mentor and train additional staff on medical coding processes as necessary

• Assign and balance coding activities amongst medical coding staff and review coding for consistency across studies

• Work on various EDC systems to perform medical coding activities

• Stay current with industry medical coding standards and innovative tools

• Assess impact of dictionary changes and the impact on projects

• Work with lead data manager and biostatistician to define project dictionary up-version strategies

• Represent SDC in internal and external audits on medical coding process expert

• Work with Clinical Programmers to develop and test project coding database and ensure User Acceptance Testing (UAT) on medical coding fields is successfully completed

• Assist Business Development on pricing and timing of coding only projects

• Act as project lead on coding only projects and submissions

• Review project medical coding requirements and communicate to appropriate team members to ensure compliance

• Contribute and approve the Medical Coding Convention section of the Data Management Plan

• Post queries on clinical database as needed to ensure accurate medical coding

• Provide status and medical coding counts on all projects

• Adhere to all aspects of the SDC’s quality system

• Comply with SDC’s data integrity & business ethics requirements

• Perform other related duties as assigned

• 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

• Exceptional working knowledge of clinical trials and coding specialist role in the drug development process

• Excellent organizational skills

• Highly effective communication skills, both written and verbal

• Technical skills including: MedNet and Medidata Coder or other coding systems, Microsoft Office

• Ability to work as a part of a team and independently

• Ability to work under tight timelines

Education or Equivalent Experience

• Bachelor’s degree in applied or life science and 8-10 years of experience in clinical data management field.

• Minimum of 5 years of experience in coding with WHODrug and MedDRA.

• Minimum of 3 years of experience leading medical coding projects. Certified Medical Coder through MSSO preferred.

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

See more jobs at Statistics & Current Openings

Apply for this job

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

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.

Primary Responsibilities

• Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity

• Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams

• Review the Statistical Analysis Plan in preparation for programming the planned analyses

• Lead design/development of SAS macros and other utilities to expedite SAS programming activities

• Organize and conduct internal training sessions and author papers for conferences

• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request

• Participate in statistical program validation and quality control activities

• Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets

• Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines

• Develop define.xml, study data reviewers guide and analysis datasets reviewers guide

• Identify study priorities and communicate effectively with project team and management

• Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours

• Manage statistical programming timelines, budgets, and client expectations

• Actively participate in study team meetings

• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects

• Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management

• Program data cleaning checks, as necessary, to assist Data Management’s data cleaning activities

• Participate in installation/validation of statistical software packages throughout the software development lifecycle

• Develop and maintain the infrastructure for project files of SAS datasets and SAS code

• Mentor junior level statistical programmers by developing training plans and providing oversight of their work Ensure all programming activities and processes performed are conducted according to SDC’s standard procedures and/or sponsor requirements

• Adhere to all aspects of the SDC’s quality system

• Comply 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

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

• Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS Macros and SAS/Graph

• Strong problem-solving skills

• Able to work independently

• Excellent knowledge of statistical programming

• Proficient in manipulating and analyzing SAS data

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

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

• Good 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). Expert knowledge of CDISC SDTM and ADaM data models

• Very strong interpersonal communication, presentation, and leadership skills

• SAS Base, Advance and Clinical Trials Certification is preferred

Education or Equivalent Experience

Bachelor’s degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience.

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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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

See more jobs at Statistics & Current Openings

Apply for this job