Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a Associate Director Biostatistics join our Biostatistics team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you’ll be doing: 

• Participates and contributes to the training and development of new biostatisticians
• Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure
• Peer reviews draft statistical analysis plans and provides feedback
• Acts as Lead Biostatistician to interact with the study team and the sponsor
• Independently develops statistical analysis plans
• Performs QC of TLFs, CDISC and other analysis data sets
• Prepares specifications for CDISC and other analysis data sets
• Presents biostatistical capabilities in bid defense meetings
• Acts as an independent biostatistician on DSMBs and DMCs
• Acts as project manager for biostatistics stand-alone work
• Independently develops SAS programs to generate randomization codes

• Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group
• Supervises SAS programming and program validation for a project
• Leads efforts in the development, maintenance and adherence to departmental SOPs and guidelines
• Develops and implements strategies to actualize goals
• Ability to lead process improvement efforts
• Keep detailed records of time spent on each project to allow accurate billing
• Maintain biostatistical section of TMF
• Ability to manage and de-escalate difficult situations with clients, teams, and management
• Ability to motivate and lead a team of varying levels of status and ability
• Attend project team meetings as required
• Capability and willingness to coach and mentor others
• Demonstrated critical thinking with a history of bringing forward strategic initiatives
• Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
• Supports Business Development concerning budget and proposal development
• Directs efforts in Biostatistics project costing estimates and change order process
• Ensures that audits have appropriate Biostatistics representation
• Perform other work-related duties as assigned
• Provides consultancy to sponsors on statistical issues
• Provides oversight and reporting of project progress and financial health within Biostatistics
• Provides statistical input to Clinical Trial Reports
• Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
• Review data management documents
• Supports Business Development by preparing for and attending bid defense meetings
• Tracks hours worked on projects and forecasts hours to complete
• Tracks project revenue and backlog

What we are searching for:  

• Previous experience in clinical trials design and analysis using SAS
• Previous experience as supervisor/manager
• Prior experience using computerized information systems preferred.
• Ability to read, write, and speak fluent English; fluent in host country language.
• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
• Works with internal and external customers/vendors to meet project specific goals.
• Identifies, monitors, documents, and tracks out-of-scope activities.
• Demonstrated experience in interactions with regulatory agencies (e.g., FDA, EMA, EU member states, etc.)
• Fluent verbal, written, and interpersonal English as well as the local language(s) required for clinical trial submissions.
• Excellent team player, collaborative and able to build an effective team.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong verbal and written communication and negotiation skills.
• Excellent organizational and time-management skills, able prioritize work to meet deadlines.
• Accountable, dependable and strong commitment

Why choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

 #LI-KT1

Description

• Join Premier Consulting, a division of Premier Research, and be a part of a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
  
  We're looking for an Associate Director, Business Development to join our Business Development team! This is a permanent role and can be located anywhere in the US. 
  
  What you'll be doing:
  
  • Engaging effectively with the prospect’s C-suite and key project stakeholders to develop relationships.
  • Discover information about business environment and decision making; company and project goals; product pipeline and priorities; and specific product development and regulatory needs.
  • Introduce Premier Consulting and its solution capabilities to develop prospect’s knowledge of and confidence in Premier Consulting's expertise and differentiation.
  • Bridge between business and scientific issues to ensure project opportunities are designed to effectively address critical business, development and regulatory goals.
  • Work with Sales Operations and Finance teams to prepare and price proposals in a timely manner.
  • Present proposals to prospects. Identify and overcome objections. Negotiate key terms to advance opportunities.
  • Influence prospect decision making at critical times in the business development process by leveraging scientific colleagues to complete solution design and demonstrate Premier Consulting's expertise.
  • Manage client onboarding collaboratively with other internal stakeholders to foster positive client experience and enable successful project kick-offs.
  • Share learnings with Marketing team and Development and Regulatory team about market segments, buyer personas, and prospect needs to influence solution design and enable successful lead generation.
  • Utilize CRM throughout the business development process to drive personal and team productivity. Update all Opportunity, Account, and Contact records appropriately to reflect business activity.
  • Manage pipeline effectively to maintain opportunity velocity and optimize personal production against goals. Respond to all prospect requests in a timely manner.
  • Prepare regular forecasts to improve visibility of future contract signings and revenue.
  • Effectively transition newly signed customers to Program Management and Operations teams
  • Travel to industry events throughout the year; low travel requirements
  You'll need this to be considered:
  
  • Knowledge and skills at a level normally acquired through the completion of a Bachelor’s, Master’s or PhD in a scientific field required.
  • 5+ years’ experience sales experience with a CRO or similar organization that supports biopharma research and development.
  • Consultative sales experience with successful track record of performance against quotas and related goals.
  • Understanding of the mechanisms and processes of drug development and approval n the United States preferred.:
  • Ability to travel as needed for inter-office, conferences, trade shows, and client meetings. Travel is expected to be <25%.
  Why choose Premier Research?  
  
  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
  Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. 
  
  We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
  
  Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.