FSP Principal Biostatistician, Study Powering and Design

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Job Title: FSP Principal Biostatistician, Study Powering and Design Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Job Level: FSP Principal Biostatistician, Study Powering and Design Location: Home-based in the U.S. or Canada Why DSSS? Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market. Job Summary: The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. Additional Benefits: Home-based remote working opportunities. Work/life balance as well as flexible schedules. Collaborating with motivated, high-performance, statistical and research teams. Technical training and tailored development curriculum. Research opportunities that match your unique skillset. Promising career trajectory. Job stability: long-term engagements and re-deployment opportunities. Focus on bringing new therapies to market rather than project budgets and change orders. Experience with regulatory submissions. Engaging, fast-paced environment. Good work-life balance. Job Responsibilities: Collaborate with multi-disciplinary project teams to establish project objectives and timelines. Perform samples size and power calculations for optimizing study design Author statistical analysis plans. Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. Author or review analysis dataset and TLF specifications Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF) Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc. Interpret study results and review reports of study results for accuracy. Support exploratory analyses. Participate in IND or NDA activities. Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety). Qualifications (Required) PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience. MS in Statistics, Biostatistics, or related field with 5+ years of industry experience. At least 2 years in Phase 2/3 clinical trial experience. At least 3 years of experience in supporting simulations, sample size and power calculations Demonstrated ability to work pro-actively and independently. Able to effectively communicate statistical ideas and collaborate with cross-functional teams Ability to efficiently use R or SAS to perform analyses. Support of various regulatory submissions Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards. Experience in validation/programming of ADAM and TLF Experience with CDISC, including SDTM, ADAM, CDASH Solid understanding of estimands and multiple imputation methods. Desired Experience: Supporting written communications with regulators. 1+ years of experience with immunology therapeutic area. Bayesian methods IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and po

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