Senior Manager - Biostatistics (Remote)
Job DescriptionA 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. Experience: 5 years required