# FSP Principal Biostatistician, Medical Affairs

**Company**: IQVIA
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Salary**: $111,000.00 - $309,000.00
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/FSP-Principal-Biostatistician--Medical-Affairs_R1574034?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_21761847-878

## Description

We are seeking a highly skilled FSP Principal Biostatistician, Medical Affairs to join our team.

As a Principal Biostatistician, you will be responsible for providing statistical analysis support for pharmaceutical research in Phase 2 and 3 clinical trials.

**Responsibilities:**

- Collaborate with multi-disciplinary project teams to establish project objectives and timelines.

- Author statistical analysis plans.

- Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations to provide statistical expertise.

- Contribute to publications and presentations.

- Provide guidance and supervision to programmers in planning and execution of analysis.

- Independently program or validate statistical outputs (tables, listings and figures) using SAS or R.

- Interpret study results and review reports of study results for accuracy.

- Support exploratory analyses.

**Qualifications:**

- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.

- MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.

- At least 3 years in Phase 2/3 clinical trial experience.

- Demonstrated ability to work proactively and independently in a fast-paced environment.

- Able to effectively communicate ideas and manage programmers in a constructive manner.

- Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.

- Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.

- Experience with CDISC, including SDTM, ADAM, CDASH.

**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
- SAS
- R
- CDISC
- SDTM
- ADAM
- CDASH
- ICH GCP
- ICH E9

### Nice to have
- peer-reviewed publications
- presentations

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/FSP-Principal-Biostatistician--Medical-Affairs_R1574034?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)