Associate Director, RWE Biostatistics

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, and 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. Remote remote from anywhere in the U.S. Contract Type full-time Responsibilities 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 of 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. Desired Education And Skills MS or Ph.D. in statistics/biostatistics or related discipline with 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 and R, Python, Snowflake are 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 CRO’s and/or contractors Ability to work independently and act with an initiative to address issues #J-18808-Ljbffr Atorus