The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. Responsibilities include collaborating with multi-disciplinary project teams to establish project objectives and timelines; writing statistical sections of clinical trial protocols; authoring statistical analysis plans; monitoring internal and CRO project activities including timelines, deliverables, and availability of resources; collaborating with Data Management, Clinical Development, and Clinical Operations with statistical expertise; contributing to clinical study reports and other regulatory documents such as NDA, DSURs, Briefing Documents, ISS, ISE; providing guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures; performing validation of analysis variables and statistical outputs; interpreting study results and reviewing reports for accuracy; supporting exploratory analyses; participating in pre-IND or NDA activities; and supporting Biostatistics and the Development Team as needed. Qualifications include a PhD in Statistics, Biostatistics, or related field with 5+ years industry experience or MS with 7+ years; at least 3 years in Phase 2/3 clinical trial experience; ability to work proactively and independently; effective communication and management of programmers; proficiency in R or SAS; understanding of ICH GCP, ICH E9, and industry standards; experience with CDISC including SDTM, ADAM, CDASH. Desired experience includes multiple imputation methods. The role offers home-based remote working opportunities, flexible schedules, technical training, research opportunities, career trajectory, job stability, and a focus on bringing new therapies to market.
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