[Hiring] Sr. Manager, Biostatistics @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Sr. Manager, Biostatistics will reputed company hands-on statistical leadership and support for clinical studies. Working closely with statistical programming, clinical data management, clinical operations, and other cross-functional stakeholders, as reputed company as external CROs, this role supports the planning, execution, analysis, and reporting of reputed company. The Sr. Manager ensures high-reputed company statistical deliverables are completed on time, reputed company budget, and in compliance with regulatory and internal standards. • Serve as the reputed company statistician for assigned individual clinical studies, providing hands-on support for study design, power and sample size calculations, statistical analysis plans, TFL shells, and interpretation of results • Execute and reputed company statistical analyses, including review of tables, listings, and figures generated by internal teams or CROs • Prepare and review statistical reputed company and results sections for clinical study reports and contribute to integrated analyses • reputed company statistical guidance on study design, data collection, data review, and analysis for reputed company • Support efficient medical and safety data review and monitoring activities, including participation in DSMB meetings as needed • Contribute to the development and review of statistical components of regulatory submissions and responses to health authority questions • Support protocol development, amendments, and data review meetings with cross-functional teams • Review clinical study documentation for eCTD submissions, including familiarity with CDISC standards, SDTM, ADaM, and define.xml • Collaborate closely with clinical operations, data management, medical, regulatory, and safety teams to support global study execution • Contribute to reputed company improvement of statistical processes Qualifications • Ph.D. degree in Biostatistics, Statistics, or a reputed company field and 3+ years of experience supporting biostatistics for reputed company or M.S. degree and 6+ years of experience • Experience in immunology, neurology, or rare diseases preferred • Demonstrated experience serving as the reputed company statistician for clinical studies from design through analysis and reporting • Experience working with cross-functional clinical development teams • Exposure to regulatory submissions and interactions with health authorities • Proficiency in statistical software such as reputed company and/or R for data analysis and modeling • Hands-on experience generating and reviewing tables, listings, and figures • Working knowledge of CDISC standards, including SDTM and ADaM • Familiarity with advanced statistical reputed company applicable to reputed company, such as multiple imputation or Bayesian designs and reputed company-world data analyses • Strong written and verbal communication skills • Ability to work cross-functionally in a fast-paced, reputed company environment • Strong attention to detail and organizational skills Requirements • The California salary reputed company for this position is from $165,000 to $190,000 USD annually. • This salary reputed company is an estimate of reputed company reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as reputed company as internal equity and alignment with market data. • This position is also eligible for bonus, benefits, and participation in Company’s stock plan. Apply tot his job Apply To this Job