Senior Statistical Programmer

Senior Statistical Programmer

Location: Remote/Hybrid

We are seeking an experienced Senior Statistical Programmer with proven expertise in Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) pooling studies. The successful candidate will play a key role in planning, developing, and delivering integrated datasets, analyses, and regulatory submission outputs across multiple clinical studies.

This position requires strong hands-on SAS programming skills, in-depth knowledge of CDISC standards, and experience supporting NDA/BLA/MAA submissions.

Key Responsibilities:

• Lead statistical programming activities for ISS/ISE analyses and pooled clinical trial datasets.
• Design, develop, validate, and maintain integrated ADaM datasets across multiple studies.
• Create pooled SDTM and ADaM specifications and ensure consistency across studies.
• Develop and validate Tables, Listings, and Figures (TLFs) for integrated regulatory submissions.
• Collaborate with Biostatistics, Data Management, Medical Writing, and Clinical teams to define pooling strategies and analysis requirements.
• Perform data integration, reconciliation, and quality review across multiple studies.
• Support NDA, BLA, MAA, and other global regulatory submissions.
• Review statistical programming deliverables to ensure compliance with SOPs, industry standards, and regulatory expectations.
• Contribute to programming standards, macros, automation initiatives, and process improvements.
• Provide technical guidance and mentorship to junior programmers.

Required Qualifications:

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• 10+ years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated experience delivering ISS/ISE pooling studies for regulatory submissions.
• Strong proficiency inSAS programming.
• Extensive experience with CDISC SDTM and ADaM standards.
• Experience creating and validating integrated datasets from multiple clinical studies.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Experience developing submission-ready TLFs and analysis datasets.
• Excellent problem-solving, communication, and stakeholder management skills.
• Ability to work independently within a global, cross-functional team environment.

Join Veramed and contribute to the successful delivery of complex regulatory submissions that help bring innovative therapies to patients worldwide