Job Title:
Senior Statistical Programmer

Experience Required:
6–10 years

Employment Type:
Permanent

Work Mode:
Remote

Roles & Responsibilities

ADaM & TLF Programming
- Lead the development and validation of
ADaM datasets
(Safety, Efficacy, PK/PD) following CDISC ADaMIG standards.
- Develop, validate, and execute
Tables, Listings, and Figures (TLFs)
for Clinical Study Reports (CSRs), interim analyses, and ad-hoc requests.
- Author and review ADaM dataset specifications and TLF shell mock-ups.
- Perform independent Quality Control (QC) and double programming for critical datasets and analysis outputs.

End-to-End Clinical Study Leadership
- Serve as the Lead Programmer for Phase I–IV clinical trials and ISS/ISE integration studies.
- Manage the complete programming lifecycle from raw data through SDTM, ADaM, TLFs, and regulatory submissions.
- Review study documents including Protocols, Statistical Analysis Plans (SAPs), Annotated CRFs (aCRFs), and data management specifications.
- Support regulatory submission activities, including Define.xml, ADRG, SDRG,



Pinnacle 21 validation, and eCTD packages.

Process & Technology
- Develop reusable SAS macros and standardized programming templates.
- Utilize R and SQL for data manipulation, reporting automation, and workflow improvements.
- Mentor junior programmers and provide technical guidance.
- Ensure compliance with company SOPs, ICH-GCP, FDA/EMA regulations, and 21 CFR Part 11.

Requirements

Experience
- 6–10 years of Statistical Programming experience in a CRO, Pharmaceutical, or Biotechnology environment.
- Proven experience leading end-to-end clinical studies.

Technical Skills
- Advanced SAS Programming (Base SAS, SAS STAT, SAS GRAPH, SAS MACRO).
- Robust expertise in ADaM dataset creation and ADaMIG standards.
- Extensive experience developing Tables, Listings, and Figures (TLFs).
- Working knowledge of SDTM and SDTMIG.
- Experience with Clinical Study Reports (CSR), SAP, aCRF, Define.xml, ADRG, SDRG, Pinnacle

📌 Senior Statistical Programmer (India)
🏢 RapidBrains
📍 India