Associate Director, Biostatistics - Genetic Medicine

In This Role, a Typical Day Might Include

• Lead Biostatistics efforts with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, and design/analyze clinical experiments and interventional studies.


• Represent statistical issues in regulatory agency meetings.


• Lead development and delivery of training to non-statistical colleagues; develop new infrastructure and processes.


• Represent the company in professional associations, conferences, and publications.


• As an Associate Director: mentor and oversee less experienced statisticians; potential to manage full-time staff.

This Role Might Be For You If Can

• Represent Biostatistics at Global Clinical sub-teams.


• Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, and Medical Writing to design and analyze clinical trials.


• Lead regulatory interaction materials (e.g., draft analysis plan, review TFLs, develop advisory committee slides).


• Lead/contribute to process improvement, technical working groups, and SOP development; set deliverable timelines/expectations.


• Evaluate software appropriateness for planned analyses; determine needs for novel statistical methodology/tools.


• Prepare presentations and written reports; co-present to management.


• Conduct research in innovative statistical methods and provide training to non-statisticians.

To be considered, you must have

• PhD (or equivalent) in statistics/biostatistics with >6 years in pharma OR MS in statistics/biostatistics with >11 years in pharma.

Preferred

• Hematology, IO, non-oncology, Multiple Myeloma experience (or similar therapeutic area).

Additional qualifications/skills

• Time to Event (TTE) experience.


• Knowledge of drug discovery/development; integrate statistical concepts into strategies.


• Strong influence/leadership and cross-functional collaboration.


• Ability to work in fast-paced environments; critical thinking, time management, effective communication.


• Solid knowledge of statistical analysis methodologies and experimental/clinical trial design.


• Expertise in statistical software.