Associate Director, Biostatistics

Associate Director, BiostatisticsOur client is a well-funded, publicly traded clinical-stage biotechnology company developing a portfolio of novel biologic therapies targeting large immunology and inflammation indications. Their pipeline focuses on validated biological pathways and advanced antibody engineering designed to improve efficacy, durability, and dosing profiles compared to current therapies.With multiple clinical-stage programs and a leadership team with a strong track record in drug development, the company is focused on delivering differentiated therapies for patients with significant unmet medical needs.The organization offers a fast-paced, highly collaborative environment where employees have the opportunity to contribute meaningfully across programs and play a visible role in advancing innovative therapeutics.Role SummaryThe company is seeking an Associate Director of Biostatistics to serve as the statistical lead across one or more clinical development programs.In this role, you will provide strategic and technical statistical leadership supporting study design, clinical trial execution, regulatory deliverables, and scientific publications. You will partner closely with cross-functional teams including Clinical Development, Clinical Operations, Data Management, and Regulatory Affairs.You will also oversee external CRO and vendor biostatistics teams to ensure the successful execution and statistical integrity of clinical trials.Key ResponsibilitiesServe as the statistical lead for one or more clinical development programsProvide expert input on clinical trial design, statistical methodology, and development strategyAuthor or review statistical sections of:Clinical protocolsStatistical Analysis Plans (SAPs)Clinical Study ReportsRegulatory submissionsScientific publications Perform or review sample size calculations and power analysesOversee CRO and vendor biostatistics activities including:TFL developmentInterim analysesData Monitoring Committee supportDatabase lock activities Contribute to regulatory interactions and submission preparationConduct exploratory analyses and provide statistical support for internal and external presentationsEvaluate innovative statistical approaches and study design methodologiesEnsure timely delivery of high-quality statistical outputs across clinical programsIdeal Candidate ProfilePhD in Statistics or Biostatistics preferredCandidates with an MS in Statistics, Biostatistics, or related field and significant industry experience will also be considered 8+ years of industry biostatistics experience supporting clinical trialsExperience supporting Phase 2 and Phase 3 clinical studiesPrior involvement in regulatory submissions preferredExperience working in matrixed clinical development environmentsAbility to communicate complex statistical concepts to cross-functional teamsExperience managing CROs and external vendorsStrong knowledge of:Clinical trial statistical methodologyAdaptive and Bayesian trial designMissing data imputation and multiplicity adjustmentsEstimands and modern regulatory statistical frameworks Proficiency in SAS, R, or similar statistical programming toolsKnowledge of CDISC standards including SDTM and ADaMFamiliarity with ICH, FDA, and EMA regulatory guidanceExperience designing and running clinical trial simulations preferredRemote position within the United StatesApproximately 10-15% travel for team meetings and key clinical development milestonesCompensationThe anticipated base salary range for this position is $195,000 - $215,000, depending on experience, background, and geographic location.The role also includes a competitive bonus structure, equity participation, comprehensive health benefits, and generous paid time off.

Created: 2026-04-02