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. #J-18808-Ljbffr Scorpion Therapeutics