FSP Principal Biostatistician, Late PhaseLocation: 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.Job SummaryThe Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.Additional BenefitsHome-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 ResponsibilitiesCollaborate with multi-disciplinary project teams to establish project objectives and timelines.Author statistical analysis plans.Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.Author or review analysis dataset and TLF specificationsValidation 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).QualificationsPhD 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.Demonstrated ability to work pro-actively and independently.Able to effectively communicate ideas and collaborate with cross-functional teamsAbility to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.Support of various regulatory submissionsUnderstanding 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.Desired ExperienceSupporting written communications with regulators.1+ years of experience with immunology therapeutic area.Bayesian methods