Role Overview

We are seeking two experienced Senior Statistical Programmers with deep expertise in CDISC standards (SDTM & ADaM) and TLF generation to support global clinical trials. The role involves end-to-end programming support across study start-up, conduct, submission, and regulatory interactions.

Key Responsibilities

1. CDISC Programming

Develop and validate SDTM datasets in compliance with CDISC standards.
Create and quality-check ADaM datasets aligned with SAP and regulatory requirements.
Ensure traceability between raw data, SDTM, ADaM, and TLF outputs.
Perform Define.xml generation and validation (if applicable).

2. TLF (Tables, Listings, Figures)

Program and validate Tables, Listings, and Figures as per SAP specifications.
Generate efficacy, safety, PK/PD, and exploratory outputs.
Perform independent validation and QC of statistical outputs.

3. Regulatory & Submission Support

Support NDA/BLA/MAA submissions (FDA/EMA/PMDA preferred).
Address regulatory queries related to datasets and outputs.
Ensure compliance with ICH, GCP, and CDISC guidelines.

4. Study-Level Ownership

Lead programming activities for assigned clinical studies.
Provide timelines, effort estimates, and risk mitigation plans.
Collaborate with Biostatistics, Data Management, and Clinical teams.
Mentor junior programmers (if applicable).

Technical Skills Required

Strong expertise in SAS programming (Base SAS, SAS/STAT, SAS Macro).
Hands-on experience in:
SDTM implementation
ADaM dataset creation
TLF programming
Experience in Pinnacle 21 validation.
Knowledge of Define.xml generation tools.
Exposure to oncology, immunology, or rare disease studies preferred.
Understanding of submission-ready datasets.

Qualification

Bachelor’s/Master’s in Statistics, Biostatistics, Mathematics, or related field.
8+ years of statistical programming experience in clinical trials.