Full-Time

Director of Biostatistics

Updated on 1/8/2025

Formation Bio

Formation Bio

51-200 employees

Accelerates drug development using AI technology

AI & Machine Learning
Biotechnology
Healthcare

Compensation Overview

$217k - $285kAnnually

+ Equity + Generous Perks + Hybrid Flexibility + Comprehensive Benefits

Senior, Expert

New York, NY, USA + 1 more

More locations: United States

Primary focus on candidates in NYC and Boston; remote candidates may be considered based on qualifications.

Category
Bioinformatics
Computational Biology
Genomics
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
R
Google Cloud Platform
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.
  • 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.
  • 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, 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.

Formation Bio focuses on speeding up the process of developing new drugs by using its own AI-driven platform. This platform helps the company identify and acquire clinical-stage assets, which are drugs that are already in testing phases. By using flexible financing options, Formation Bio aims to lower the high costs and long timelines usually involved in drug development, making new treatments more accessible and affordable for patients. The company works with pharmaceutical and biotech firms to help them develop their drugs more quickly and efficiently. Its unique approach combines advanced technology with strategic partnerships to improve drug selection and development, with the goal of successfully bringing new drugs to market.

Company Stage

Series D

Total Funding

$515.8M

Headquarters

New York City, New York

Founded

2013

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

1%
Simplify Jobs

Simplify's Take

What believers are saying

  • $372M Series D funding boosts platform expansion and asset acquisition capabilities.
  • Collaboration with OpenAI and Sanofi advances AI-driven drug discovery standards.
  • Precision genomics partnership with SomaLogic improves biomarker identification and patient stratification.

What critics are saying

  • Competition from other AI-driven drug developers may impact market share.
  • Regulatory scrutiny on AI processes could lead to delays and compliance costs.
  • Dependence on partnerships poses risks if collaborations dissolve or underperform.

What makes Formation Bio unique

  • Formation Bio uses AI to accelerate drug development, reducing costs and timelines.
  • The company acquires clinical-stage assets, enhancing drug development flexibility and efficiency.
  • Partnerships with major pharma firms provide access to proprietary data and resources.

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Benefits

Company Equity

Remote Work Options

Flexible Work Hours