Senior Manager - Biostatistics (Remote)

A biotech company is actively seeking a new Senior Manager, Biostatistics for a great Remote opportunity with their staff.Responsibilities:Contribute to study level tasks from statistics perspective, including study design and sample size determinationAuthor/review statistics section in the protocol, SAP and DMC charterCreate/review study randomization files; develop TFL shell and specification; review CRFs and other study documentationsWork collaboratively within the Biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reportingEnsure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirementsIndependently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study resultsContribute to developing standards and research in advanced statistical methodologiesAuthor/review regulatory documents or scientific publicationsQualifications:PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 years for Master's degree) of post-graduate experience in the Clinical Trials setting in the Pharmaceutical industryExperienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interactionExperienced as a Study Lead Statistician and contributing to strategy discussion in cross functional settingsExperienced in study level work including authoring SAP and TFL specificationFamiliar with ICH guidelines, FDA / EMA / other regulatory authority guidanceSolid understanding of Mathematical and Statistical principlesDetailed-oriented with organization, problem solving and prioritization skillsDesired Skills:Familiar with SAS and R with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

Created: 2025-10-07