About This Role
This role is for an Associate Director of Biostatistics who will be a member of cross-functional Development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director can support a particular indication of an asset. The individual will develop collaborative relationships with the Biostatistics indication/asset Lead and other cross-functional team members.
Responsibilities
- Collaborate in the design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contribute to project development strategy
- Defend protocols and analysis plans at internal governance reviews and provide independent reviews of complex protocols
- Independently author and/or review protocols, statistical analysis plans, clinical study reports, associated publications, and other study level documents
- Present summary data and analyses results in a clear, concise, complete, and transparent manner
- Provide statistical support and leadership to address health authority requests, publications, presentations, and other public release of information
- Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
- Apply extensive knowledge of statistical/clinical trials methodology as it relates to clinical development
- Invest in developing knowledge outside of traditional statistical expertise in the clinical, regulatory, and commercial environments with demonstrated application to study design
- Effectively engage as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process
- Comply with BMS processes and SOPs, adhere to global and project standards within an indication or therapeutic area, and be responsible for the quality of deliverables
- Contribute to external and internal statistical community of practice
- Develop and advise team members
- Effectively communicate the DQS Mission and Vision in a fashion that generates pride, excitement, and commitment within DQS
Requirements
- PhD (6+ years’ experience) or MSc (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 & simulation
- Great interpersonal, communication, writing and organizational skills
- Expertise in statistical/clinical trials methodology as it relates to clinical development and ability to apply to relevant clinical development framework
