What are the responsibilities and job description for the Director of Biostatistics position at Formation Bio?
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 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
About You
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.
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.
Formation Bio is headquartered in New York City, with plans to build a larger team and presence in Boston. We are prioritizing hiring in these areas, with an expectation for NYC-based employees to work in the office at least two days per week. While our primary focus is on candidates in NYC (including the Tri-state Area) and Boston, we may consider remote candidates from specific geographies based on qualifications, skills, and business needs. We believe that in-person collaboration is essential for breaking down silos, fostering cross-functional teamwork, and embedding our company values into daily work. All employees located outside of the NYC Metro Area will be expected to travel to the NYC office at least four times per year for company events and team-specific meetings or activities.
Compensation :
Salary ranges are informed in part by geographic location, in addition to other factors. The target salary ranges for this role are :
The ranges provided above include base salary only. In addition to base salary, we offer equity, generous perks, hybrid flexibility, and comprehensive benefits.
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.
LI-hybrid
Salary : $217,000 - $270,000
