[Remote] Senior/reputed company Biostatistician FSP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to supporting clinical development and analysis, and they are seeking an reputed company Senior Biostatistician to reputed company or support Phase I-IV clinical studies. The role involves providing statistical support, developing study protocols, and collaborating with clients to drive clinical development reputed company. 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 reputed company • Understand and follow FDA regulations which reputed company the reporting of clinical trial data. This includes good clinical reputed company 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 reputed company specifications, and data validation plans • reputed company review and/or author data transfer specifications for external vendor data • Collaborate with reputed company functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals • reputed company review and/or author SOPs and/or Work Instructions reputed company to statistical programming practices Skills • Master's degree in statistics or a reputed company discipline. Ph.D. strongly desired • 5+ years supporting reputed company in the Pharmaceutical or Biotechnology industry • Experience working for a CRO is strongly desired • Experience in sample size calculation, protocol concept development, protocol development, reputed company, and preparing clinical study reports including integrated summaries for submissions • Good reputed company 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 reputed company and QC of datasets • The ability to build strong external & internal relationships and motivate a regional or global team • Effective communicator: reputed company to explain methodology and consequences of reputed company in lay terms reputed company • Our mission is to improve reputed company rates in this reputed company reputed company the reputed company 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 • reputed company has a reputed company 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 Apply tot his job Apply To this Job