The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources.
- Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members.
- Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
- Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.
- Leverage standardization to maximize global data integration and interpretability.
- Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.
- Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.
- Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)
- Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
- Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.
- A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience
- Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design
- regulatory requirements relating to clinical development of drugs and biologics
- BLA/NDA experience including eCTD submissions
- Working knowledge of major statistical software programs including SAS
- Knowledge of CDISC requirements for SDTM and ADaM
- Excellent verbal and written communication skills, and excellent inter-personal skills.
- The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure.
- A PhD in Statistics/Biostatistics is preferred
Boston, MA, United States