Statistical Programmer (m/f/d)
EPM Scientific are currently partnered with a leading pharmaceutical company seeking a Freelance Statistical Programmer to support ongoing clinical development activities. See a short summary below:
Contract Conditions:
- Start date: ASAP
- Location: Europe, Remote
- Contract: Freelance, 6-12 Month Contract
- FTE: Flexible (0.8-1.0 FTE)
- Language: English
- Project Area: Clinical Trials / Submission Support
Key Responsibilities:
- Support integration of new clinical trial data into an existing pooled analysis dataset.
- (Re-)Creation and validation of Tables, Listings, and Figures (TLFs) for clinical study reporting.
- Develop and perform Quality Control (QC) on programming documentation including Define.xml, Reviewer's Guide, and other submission-related deliverables.
- Collaborate with cross-functional teams including Biostatistics, Data Management, and Regulatory Affairs.
- Contribute to submission readiness and ensure programming deliverables meet regulatory standards.
Requirements:
- Proven experience as a Biostatistical Programmer in the pharmaceutical or CRO environment.
- Hands-on experience with clinical trial data integration and submission deliverables.
- Strong proficiency in SAS programming and CDISC standards (ADaM, SDTM).
- Prior involvement in regulatory submissions (e.g., FDA, EMA) is highly desirable.
- Excellent attention to detail and documentation skills.
If this opportunity aligns with your experience and availability, please apply directly to learn more. If not, feel free to share with your network.
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