Associate Director, Biostatistics – AI

This is a fully remote position, open to applicants in United States.

📋 Description

• The Associate Director of Biostatistics & AI will oversee the provision of high-quality statistical analyses.

• Responsible for designing, constructing, and integrating AI/ML interfaces into the everyday operations of the biometrics department.

• Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.

• Supervise CRO statisticians and programmers for the designated programs.

• Utilize suitable statistical methodologies to support medical insights, value demonstration, safety monitoring, and lifecycle management.

• Contribute to the statistical design, analysis, and reporting for Phase II–IV clinical trials, incorporating adaptive designs, Bayesian methods, and estimands in accordance with ICH E9(R1).

⛳️ Requirements

• PhD or Master’s degree in Biostatistics, Statistics, Computer Science, Artificial Intelligence, Data Science, or a closely related quantitative discipline.

• 5+ years of experience in pharmaceutical biostatistics within drug development, biotech, or CRO environments for PhD holders, or 7+ years for Master’s degree holders (Track A); alternatively, a minimum of 3 years of practical AI/ML engineering experience (Track B).

• Expert-level skills in SAS and/or R; a working knowledge of Python for data science or scripting is also required.

• Proven experience with AI/ML tools, such as LLM APIs, prompt engineering, or automation scripting, with a keen interest in enhancing these skills within a GxP environment.

• Extensive knowledge of CDISC standards (SDTM, ADaM, Define-XML) and regulatory submission processes; experience with NDA/BLA/MAA submissions is preferred.

• Strong proficiency in Python for AI/ML development; familiarity with SAS and/or R in a statistical or data science context is necessary (Track B).

• Significant exposure to clinical or life sciences data—such as working with clinical trial datasets, CDISC standards, pharmacovigilance data, or regulated environments (GxP/21 CFR Part 11)—with a desire to further develop expertise in this area (Track B).

• Basic understanding of statistical concepts (e.g., hypothesis testing, regression, survival analysis) relevant to clinical development.

🏝️ Benefits

• Competitive compensation package.

• 401K plan with a 100% employer match on the first 3% and 50% match on the following 2%.

• Employee stock purchase program available.

• Pre-tax commuter benefits offered.

• Referral program providing a $2,500 reward for successful hires.

• Comprehensive health insurance with 100% of premiums covered—at no cost to you or your dependents.

• Mental health support through Spring Health, offering 6 therapy sessions and 6 coaching sessions.

• Hybrid work model allowing employees flexibility in their work environment.

• Unlimited flexible paid time off—take the time you need.

• Paid parental leave, providing 4 months for birthing parents and 2 months for non-birthing parents.

• Flexible spending accounts and company-provided group term life and disability insurance.

• Subsidized lunch through Forkable on days worked from our office.