Associate Director, RWE Biostatistics

Role Description

The successful candidate will serve as a senior statistical lead supporting an active regulatory submission program. The role will focus on:

• Statistical review
• Submission readiness
• Analysis traceability
• Reviewer-facing documentation
• Cross-functional resolution of statistical and data issues

The individual must be comfortable operating in a fast-paced environment with compressed timelines and significant interaction across Biometrics, Regulatory Affairs, Medical Writing, Statistical Programming, and external partners.

Qualifications

• MS or Ph.D. in statistics/biostatistics or related discipline
• At least 9 years of experience in the pharmaceutical or biotech industry
• Demonstrated ability and experience in the analysis and reporting of real-world studies (retrospective and prospective)
• Experience in NDAs, MAAs or other regulatory submissions
• Knowledge of immunology, rare diseases and/or gene therapy is desirable
• Proficient in statistical programming (SAS is required; R, Python, Snowflake are a plus)
• Ability to concurrently lead statistical efforts for multiple projects simultaneously
• Understanding of data standards, including CDISC SDTM, ADaM, eSub requirements
• Adept at overseeing statistical services provided by CROs and/or contractors
• Ability to work independently and act with initiative to address issues

Requirements

• Provide statistical and methodological study expertise on assigned projects
• Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
• Validate the results of key statistical deliverables
• Plan and perform ad hoc and exploratory statistical analyses as needed
• Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results
• Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions
• Address statistical questions/comments from FDA and other regulatory agencies
• Review and challenge CRO/vendor-derived analyses
• Reconstruction of third-party analysis workflows (RMD) into submission-ready ADaM structures
• Ability to trace results back to datasets and source analyses

Company Description