[Remote] Senior/Principal Biostatistician FSP

Note: The job is a remote job and is open to candidates in USA. Cytel is a company dedicated to supporting clinical development and analysis, and they are seeking an experienced Senior Biostatistician to lead or support Phase I-IV clinical studies. The role involves providing statistical support, developing study protocols, and collaborating with clients to drive clinical development forward. Responsibilities • Providing statistical support to clinical studies • Participating in the development of study protocols, including participation in study design discussions and sample size calculations • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications • Performing statistical analyses and interpreting statistical results • Preparing clinical study reports, including integrated summaries for submissions • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Skills • Master's degree in statistics or a related discipline. Ph.D. strongly desired • 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry • Experience working for a CRO is strongly desired • Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus • Solid understanding & implementation of CDISC requirements for regulatory submissions • Adept in ADaM specifications generation and QC of datasets • The ability to build strong external & internal relationships and motivate a regional or global team • Effective communicator: able to explain methodology and consequences of decisions in lay terms Company Overview • Our mission is to improve success rates in this endeavor via the optimal design, effective implementation It was founded in 1987, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship • Cytel has a track record of offering H1B sponsorships, with 38 in 2025, 54 in 2024, 37 in 2023, 46 in 2022, 43 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job

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