Senior Director of Biostatistics

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

The Senior Director (program lead) of Biostatistics will report to the Senior Director of Biostatistics and serve as an important leader at Formation Bio. The Director of Biostatistics will lead all biostatistics activities for a program, driving the application of innovative quantitative approaches to the design and analysis of clinical trials and clinical development programs. In addition, the Director of Biostatistics will collaborate with Biometrics leadership and the technology team, supporting the development and implementation of tools for clinical trial design and simulation.

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.

About You

• 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.

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $275,000 - $340,000.

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

If this range doesn’t match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.