# Principal Statistical Programmer

**Company**: IQVIA
**Location**: Frankfurt, Hesse
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Frankfurt-Hesse-Germany/Principal--Statistical-Programmer--FSP---Permanent-Homebased--m-w-d_R1579657?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/principal-statistical-programmer-5d5b0d88-ea5/

## Description

We are seeking an experienced Principal Statistical Programmer to provide technical leadership across Phase I-IV clinical trials, driving the delivery of high-quality statistical programming solutions, regulatory submissions, and study-level programming strategy.

**Key Responsibilities**

- Lead statistical programming activities across multiple clinical studies and programs.

- Serve as a Study Lead, providing oversight, mentorship, and technical guidance to programming teams.

- Develop, validate, and review analysis datasets, tables, listings, and figures (TLFs) using SAS and R.

- Drive programming standards, efficiencies, and process improvements across studies and therapeutic areas.

- Author and review programming specifications, validation plans, and study documentation.

- Ensure high-quality delivery of regulatory submission packages in compliance with industry standards.

- Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional stakeholders to resolve data and programming issues.

- Support strategic initiatives through the development and implementation of reusable programming tools and solutions.

**Required Qualifications**

- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.

- Minimum 8+ years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry, demonstrating increasing levels of responsibility.

- At least 2+ years of experience as a Study Lead/Lead Programmer, leading programming activities across clinical trials; alternatively, experience developing SAS/R solutions implemented across multiple studies, programs, or therapeutic areas.

- Intermediate/Advanced programming expertise in SAS (Base and Macro) and R.

- Strong knowledge of CDISC standards (SDTM, ADaM, Pinnacle 21) and regulatory submission requirements.

- Proven experience supporting efficacy analyses, statistical reporting, and regulatory deliverables.

- Experience developing and reviewing programming specifications and technical documentation.

- Strong understanding of clinical trial data, including study population, efficacy, safety, and PK/PD analyses.

- Demonstrated leadership, project management, and organizational skills, with the ability to manage multiple priorities across studies and programs.

- Excellent communication skills with experience collaborating across cross-functional teams and engaging with key stakeholders.

**Preferred Qualifications**

- Hands-on experience with R programming in a clinical development environment.

- Experience supporting global regulatory submissions (FDA, EMA, PMDA).

- Previous experience working within an FSP model supporting pharmaceutical sponsors.

- Experience driving programming innovation, automation, and standardization initiatives.

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## Skills

### Required
- SAS
- R
- CDISC standards
- statistical programming
- regulatory submissions

### Nice to have
- R programming
- global regulatory submissions
- FSP model
- programming innovation

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