Provide biostatistical leadership to support clinical development strategy, protocol design, and endpoint selection.
Lead analysis planning and execution, including SAP development, interim/ad hoc analyses, and interpretation of study results.
Oversee statistical programming deliverables and ensure fit-for-purpose QC and traceability.
Partner cross-functionally to deliver high-quality clinical study reports and support regulatory submissions.

Requirements

Advanced degree (MS or PhD preferred) in biostatistics, statistics, or a related quantitative discipline.
Minimum 7 years of professional experience in Biostatistics and/or Statistical Programming within Clinical Research (CRO, Pharmaceutical, or Biotech).
Strong command of biostatistical principles for clinical trials, including study design, estimation, hypothesis testing, and interpretation.
Strong ability to partner with Data Management to translate protocol and SAP requirements into EDC design.
Demonstrated experience authoring/reviewing SAPs and delivering analysis outputs (TFLs).
Experience with advanced and/or applied statistical methods (e.g., longitudinal models, Bayesian or causal methods).
Working knowledge of CDISC standards (SDTM/ADaM) and traceability expectations.
Expertise in statistical programming (SAS required; R and/or Python desirable).

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

biostatisticsstatistical programmingclinical trialsstudy designhypothesis testinglongitudinal modelsBayesian methodscausal methodsSASR

Soft Skills

leadershipcollaborationcommunicationinterpretationquality controlproblem-solvingattention to detailorganizational skills