Associate Director Of Biostatistics

About Formation Bio

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

The Associate Director (indication lead) of Biostatistics will report to the Senior Director of Biostatistics and serve as an important leader at Formation Bio. The Associate Director of Biostatistics will lead all biostatistics activities for an indication, driving the application of innovative quantitative approaches to the design and analysis of clinical trials and clinical development programs. In addition, the Associate 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 indication at Formation Bio. Drive all statistical activities related to study design, study delivery, data interpretation, and regulatory submissions for the molecule.

• 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 an indication 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

• Director: 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.

• Associate Director: At least 6 years' relevant experience in the pharmaceutical and/or biotechnology industry for candidates holding an M.S. or 4 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:

• Director: 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.

• Associate director: Experience leading the statistical execution of a clinical trial as a study lead or indication lead. Detailed understanding of protocol development, SAP development, SDTM/ADaM and TFL development, and clinical study reporting is required.

• Regulatory experience:

• Director: 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.

• Associate Director: Solid understanding of biostatistics regulatory requirements and guidelines. Experience supporting interactions with health authority agencies such as FDA and EMA. Prior experience contributing to an NDA/BLA is preferred.

• 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 $155,000 - $200,000.

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.