Biostatisticien principal FSP, Puissance statistique et conception des études

IQVIA; Ottawa; On-site; CAD 140,000 - 180,000; Full time

Benefits offered by this job

Home-based remote work

Flexible schedules

Professional development

Job summary

IQVIA LLC is seeking a Principal Biostatistician (Study Powering and Design) for home-based work in the U.S. or Canada. You will provide statistical support for pharmaceutical trials, lead sample size and power calculations, and author or review SAS/R analyses and TLF specifications.

The role requires PhD or MS in Statistics with industry experience, plus strong collaboration with cross-functional teams and regulatory submission capabilities.

Qualifications

• 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.
• Experience in Phase 2/3 clinical trials and regulatory submissions.

Responsibilities

• Collaborate with multidisciplinary teams to define study objectives and timelines.
• Perform sample size and power calculations to optimize study design.
• Author statistical analysis plans and review analysis datasets.
• Validate efficacy analyses and support TLF/outputs for reports.
• Guide programmers in SAS/R and analysis dataset spec writing.
• Interpret results and contribute to regulatory documents (ISS, ISE).
• Support IND/NDA activities and ensure QC of results.

Skills

Communication of statistics

Cross-functional collaboration

Independent work

Regulatory understanding

Education

PhD in Statistics

MS in Statistics

Tools

R

SAS

CDISC

TLF/ADAM/SDTM

Job description

**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**Note**-**-We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies.**