# FSP Principal Biostatistician, Phase 2 and 3

**Company**: IQVIA
**Work arrangement**: remote
**Experience**: senior
**Job type**: contract
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Kirkland-Quebec-Canada/Biostatisticien-principal-FSP--Puissance-statistique-et-conception-des-tudes_R1572988?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_29bb8779-dc9

## Description

Data Sciences Staffing Solutions (DSSS) is a unit within IQVIA that provides sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership.

The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.

**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.

- 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.

**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.

## Skills

### Required
- Statistics
- Biostatistics
- R
- SAS
- CDISC
- SDTM
- ADAM
- CDASH
- FDA guidance
- ICH GCP
- ICH E9

### Nice to have
- immunology therapeutic area
- Bayesian methods
- regulatory submissions

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