Biostatisticien principal FSP, Puissance statistique et conception des études

** Job Level: FSP Principal Biostatistician, Study Powering and Design
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* 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.
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* 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.
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* 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
** Note**-**-We have Principal Statistician roles across all areas of FSP
- Early Phase, Late Phase aligning to various Therapeutic studies.*
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