Simplify Logo

Full-Time

Director of Biostatistics

Confirmed live in the last 24 hours

Formation Bio

Formation Bio

51-200 employees

Hardware
AI & Machine Learning
Biotechnology
Healthcare

Compensation Overview

$228k - $285kAnnually

+ Equity + Generous Perks + Location Flexibility + Comprehensive Benefits

Senior, Expert

Remote in USA

Category
Bioinformatics
Computational Biology
Genomics
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
R
Data Analysis
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.

Company Stage

Series D

Total Funding

$515.8M

Headquarters

New York City, New York

Founded

N/A

Growth & Insights
Headcount

6 month growth

2%

1 year growth

6%

2 year growth

25%
Simplify Jobs

Simplify's Take

What believers are saying

  • The recent $372M Series D funding will significantly bolster Formation Bio's expansion and product development efforts.
  • Collaborations with industry leaders like Sanofi and OpenAI could revolutionize drug discovery and development, enhancing the company's market position.
  • Formation Bio's innovative approach to clinical trials promises more efficient and faster drug development, potentially leading to quicker market entry and higher revenue.

What critics are saying

  • The high dependency on AI and technology platforms may pose risks if these technologies fail to deliver as expected.
  • The competitive nature of the pharmaceutical industry means that Formation Bio must continuously innovate to maintain its edge.

What makes Formation Bio unique

  • Formation Bio leverages a tech-driven platform to optimize clinical drug development, unlike traditional pharmaceutical companies that rely on conventional methods.
  • Their strategic partnerships with AI leaders like OpenAI and pharmaceutical giants such as Sanofi set them apart in the competitive landscape.
  • Formation Bio's focus on acquiring and accelerating the development of clinical-stage drugs enables faster access to new treatments for patients.