Manager, Biostatistics - General Medicine

Responsibilities:
- Work with cross-functional teams to articulate drug development questions, assess feasibility of endpoints, and frame statistical approaches.
- Design clinical experiments and interventional studies to generate and analyze data.
- Interpret results and support program-level decision-making.
- Co-author clinical study protocols and statistical analysis plans; perform statistical analyses for interim and final reports.
- Develop and deliver training to non-statistical colleagues.
- Collaborate on development of new infrastructure and processes.
- Influence external pharmaceutical/regulatory environment through professional associations, conferences, and publications.
- Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials.
- Determine appropriate statistical methodology; collaborate with Statistical Programming on tables, figures, and listings for decision-making and regulatory reporting.
- Evaluate software suitability for planned analyses; determine needs for novel statistical methods/tools.
- Prepare presentations and written reports for project teams, management, and regulatory agencies.

Qualifications:
- PhD (or equivalent) in statistics/biostatistics with >2 years’ pharmaceutical industry experience, or MS in statistics/biostatistics with >7 years’ experience.
- Knowledge of drug discovery and development; ability to integrate statistical concepts into development strategies.
- Excellent influence/leadership and demonstrated ability to collaborate cross-functionally.
- Ability to work in a fast-paced collaborative environment with critical thinking, time management, and effective communication.
- Solid knowledge of statistical analysis methodologies, and experimental/clinical trial design.
- Required: Expertise in statistical software such as R or SAS.

Application Instructions:
- Apply now.