Description
Leading statistical efforts for clinical studies, the full-time Senior Principal Statistician will design and report on Phase I to IV clinical studies and regulatory filings, providing expertise in statistical strategy and analysis while collaborating with cross-functional teams in a remote environment.Key responsibilitiesParticipate in meetings to optimize clinical study designs and analysis strategiesDevelop and implement study protocols, including statistical analysis plans and data validationAct as a statistical subject matter expert, preparing for regulatory agency meetings and ensuring quality deliverables from CROsRequired qualificationsMS or MPH in statistics, mathematics, or a related discipline with over 4 years of experience in the pharmaceutical or biotechnology industry, or PhD with over 2 years of experienceProficient in SAS and R programming, with knowledge of CDISC standardsExperience with clinical trial design and analysis, including complex statistical methodsFamiliarity with regulatory requirements and guidelines related to statistical analysisKnowledge of oncology or hematology therapeutic areas is preferred
Description
Leading statistical efforts for clinical studies, the full-time Senior Principal Statistician will design and report on Phase I to IV clinical studies and regulatory filings, providing expertise in statistical strategy and analysis while collaborating with cross-functional teams in a remote environment.Key responsibilitiesParticipate in meetings to optimize clinical study designs and analysis strategiesDevelop and implement study protocols, including statistical analysis plans and data validationAct as a statistical subject matter expert, preparing for regulatory agency meetings and ensuring quality deliverables from CROsRequired qualificationsMS or MPH in statistics, mathematics, or a related discipline with over 4 years of experience in the pharmaceutical or biotechnology industry, or PhD with over 2 years of experienceProficient in SAS and R programming, with knowledge of CDISC standardsExperience with clinical trial design and analysis, including complex statistical methodsFamiliarity with regulatory requirements and guidelines related to statistical analysisKnowledge of oncology or hematology therapeutic areas is preferred