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.
Solid proficiency in

SAS programming.
Extensive experience with

CDISC SDTM and ADaM

standards.
Experience creating and v

📌 Senior Statistical Programmer (Mumbai)
🏢 Veramed
📍 Mumbai