Biostatisticien principal FSP, Puissance statistique et conception des études

Location: Home-based in the U.S. or CanadaData 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. 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.

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 TLFExperience with CDISC, including SDTM, ADAM, CDASHSolid understanding of estimands and multiple imputation methods.