Biostatisticien principal FSP, Puissance statistique et conception des études in Ottawa

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 sample 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.