Principal Biostatistician

Company: Cytel, Inc (USA)
Location: Appleton
Posted on: January 18, 2023

Job Description:

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.We are hiring a remote Principal/Senior Biostatistician to work directly with a pharma company's internal team leading project efforts and providing statistics knowledge. This position reports to the Associate Director of Biostatistics in FSP Services business unit in Cytel.Your ImpactThe (Principal/) Senior Biostatistician position is part of the Research and Development team to develop and provide scientifically sound analyses that answer questions to support product development. The level of this position will be determined based on the amount of the candidate's industry experience and statistical knowledge.Essential RequirementsMS or PhD in Statistics, Mathematics, or related field with 3+ years' experienceExcellent writing, communication, and project management skills.Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards.Support clinical development biostatistics with core deliverables (SAP, CSR TLFs, etc.) and exploratory analyses necessary for submissions and regulatory queries.Experience in Neuroscience, Oncology, Early Phase, or Medical Affairs.Experience with sample size estimation (e.G., in SAS, R, N-Query, or simulation).Specification reviews, Reviewer's Guide contribution/review.An additional qualification of Principal Biostatistician: the Principal Biostatistician will bring additional experience (5+ years) and is expected to mentor/manage less experienced staff.Skills and Knowledge RequirementsExperience in a matrix team environmentExcellent written and oral communication skills and demonstrated problem-solving abilitiesAbility to work proactively while handling multiple deliverables and short timelinesComputer proficiency in SAS, Microsoft Word, Excel, and PowerPointMust be able to prioritize and multi-task, work effectively with little or no direction, and build collaborative relationships with management, partners, and peers from diverse backgrounds.Ability to work across multiple projectsDemonstrated working knowledge of GCP, ICH guidelines and FDA regulationsUnderstanding of study phases and general knowledge of how they apply to biostatics and statistical programmingDemonstrated ability to work independently and in a team environmentAbility to create and maintain of study-specific data management documentsAbility to interface cross-functionally with Data ProgrammingAbility to assist with the training of new study team members#LI-BB1#CYTELNA

Keywords: Cytel, Inc (USA), Appleton , Principal Biostatistician, Other , Appleton, Wisconsin