Senior Director of Biostatistics

Summary

Join Formation Bio, a tech and AI-driven pharma company, as a Senior Director (program lead) of Biostatistics. Reporting to the Senior Director of Biostatistics, you will lead all biostatistical activities for a program, applying innovative quantitative approaches to clinical trial design and analysis. You will collaborate with cross-functional teams, including Biometrics leadership and the technology team. This role requires extensive experience in the pharmaceutical/biotechnology industry, deep statistical expertise, and regulatory experience. Formation Bio offers competitive compensation, equity, generous perks, location flexibility, and comprehensive benefits.

Requirements

• M.S. or Ph.D. in Statistics or Biostatistics
• Experience in the pharmaceutical and/or biotechnology industry At least 8 years’ relevant experience in the pharmaceutical and/or biotechnology industry for candidates holding an M.S. or 6 years’ relevant experience for candidates holding a Ph.D
• Deep understanding of the statistical designs and methods for early and/or late phase development programs
• A passion for quantitative decision making with experience evaluating clinical trial designs and clinical development decision criteria via simulation
• Expertise in either frequentist or Bayesian approaches to study design and decision making
• Ability to effectively communicate the results of complex statistical analyses and simulations to cross functional colleagues
• Solid understanding of ICH guidelines and their implications for study design and data analysis
• Study/program execution experience: Extensive experience leading the statistical execution of multiple clinical trials as either a program lead or indication lead. Detailed understanding of protocol development, SAP development, SDTM/ADaM and TFL development, and clinical study reporting is required
• Regulatory experience: Deep understanding of biostatistics regulatory requirements and guidelines. Significant prior experience interacting with health authority agencies such as FDA and EMA. Prior experience contributing to an NDA/BLA is required
• Experience utilizing statistical software for design and analysis of clinical trials (e.g., SAS, R, EAST, FACTS)
• Proficient R programming skills are required

Responsibilities

• Lead the statistical strategy and technical activities for the development of an important program at Formation Bio
• Drive all statistical activities related to study design, study delivery, data interpretation, and regulatory submissions for the program
• Develop study designs that will advance a molecule’s clinical development plan, lead to regulatory approval, and support patient access
• Drive the quantitative evaluation of study design options, clinical development options, and go/no-go criteria through simulation studies
• Collaborate with cross-functional teams on the development of regulatory documents and attend regulatory meetings
• Lead all aspects of statistical reporting for the program and ensure compliance with data submission guidelines, including review and/or authoring of protocols, statistical analysis plans, topline study results, clinical study reports, and publications
• Oversee CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices
• Collaborate with Biometrics leadership and the technology team, supporting the development and implementation of tools for clinical trial design and simulation

Preferred Qualifications

Expert R programming skills are preferred

Benefits

• Competitive compensation
• Equity
• Generous perks
• Location flexibility
• Comprehensive benefits