Remote Director of Biostatistics

Summary

The job is for a Director (Program Lead) of Biostatistics at Formation Bio, a tech-driven pharma company. The role involves leading biostatistics activities, driving statistical strategies, collaborating with cross-functional teams, and overseeing CRO/Vendor activities. Requires an M.S. or Ph.D. in Statistics or Biostatistics, experience in the pharmaceutical industry, proficient R programming skills, and regulatory experience.

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. Expert R programming skills are preferred

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
• 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

Benefits

• Competitive compensation because we want to hire the best people and reward them for their contributions to our mission
• Equity
• Generous perks
• Location flexibility
• Comprehensive benefits