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Job Description
The Market Access/HEOR GBDS Associate Director provides statistical support to Market Access/HEOR activities. They partner with HEOR and Market Access functions and take a leading role to identify and address potential data gaps, design, prepare, and interpret analyses and data presentations to successfully enable market access and price negotiations.
Responsibilities:
* Develops expertise beyond biostatistics by researching medical literature, regulatory, and HTA documents to develop an understanding of the clinical, regulatory/HTA, and commercial climate.
* Contributes to preparation of the development strategy that will enable successful market access and price negotiation.
* Contributes to the design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives that will support regulatory approval and market access.
* Translates scientific questions into statistical terms and statistical concepts into layman terms.
* Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information.
* Ensures that all analyses conducted for MA/HEOR are scientifically sound and that the trial design and data collected support conducting the analysis. Presents summary data and analyses results, in a clear, concise, complete, and transparent manner.
* Communicates effectively with clinical and regulatory partners and external opinion leaders.
* Builds the external reputation via external interactions through engagement in external working groups, collaborations with alliance partners, academic, and government research organizations, and through conference participation.
* Reviews protocols, statistical analysis plans, associated publications, and other study-level specification documents.
* Exercises cost-disciplined science in the planning for the analyses to be conducted.
* Manages and ensures consistency and adherence to standards within an indication or therapeutic area.
* Applies extensive knowledge of statistical methodology as it relates to Market Access/HEOR analysis needs.
* Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the MA/HEOR processes.
* Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
* Develops & advises team members.
* Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement, and commitment within GBDS.
* Enables a culture of inclusiveness, respect for diversity, compliance with process, and allows for the questioning and challenging of others in a respectful and constructive manner.
Requirements for People Managers:
* Effectively engages as an employee advocate and management coach/mentor to team members - both internally and externally.
* Provides leadership to empower and develop the team.
* Provides guidance to employee's development plans and carries out performance review and feedback. Develops performance metrics for staff.
Qualifications & Experience:
* PhD (6+ years' experience) or MS (8+ years' experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry, or healthcare experience.
* Proficiency in scientific computing/programming (SAS, R, or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation.
* Great interpersonal, communication, writing, and organizational skills.
* Expertise in statistical/clinical trials methodology and ability to apply to relevant framework.
* Good understanding of regulatory & HTA landscape and relevant experience.
* Demonstrate collaboration, organizational/leadership abilities, and interpersonal skills.
* Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills.