Senior Statistical Programmer

About the role

The Senior Statistical Programmer will support multiple clinical studies by developing, validating, and delivering high‑quality statistical programming outputs. The role requires strong expertise in SAS, CDISC standards, and regulatory submission deliverables, with a focus on efficiency and compliance.

Key responsibilities

• Lead end‑to‑end programming for multiple studies and act as primary client contact.
• Develop specifications and SAS programs for SDTM and ADaM datasets.
• Create and validate Tables, Listings, and Figures (TLFs) based on statistical analysis plans.
• Design reusable SAS macros for Phase I–IV trial reporting.
• Generate submission‑ready datasets and outputs adhering to FDA, PMDA, and EMA requirements.
• Collaborate with cross‑functional teams to ensure timely, high‑quality deliverables.

Required profile

• Minimum 8 + years of experience in the pharmaceutical/biotechnology industry or IT consulting.
• Experience preparing NDA filings and knowledge of E6, E3, E9 guidelines, 21 CFR Part 11.
• Strong understanding of clinical drug development, safety reporting, and DSUR/PSUR deliverables.
• Excellent verbal and written communication skills with a detail‑oriented mindset.
• Bachelor’s degree in a health‑related or scientific field; Master’s in Statistics preferred; SAS certification required.

Required skills

• Advanced SAS programming (Base SAS, SAS/STAT, Macro, PROC SQL, PROC REPORT, PROC SUMMARY, PROC FREQ, PROC TRANSPOSE, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS).
• Proficiency with CDISC standards – SDTM and ADaM.
• R programming (tidyverse, dplyr, admiral, rtables, ggplot2, xportr, flextable).
• Version control using Git (GitHub, GitLab).
• Experience with Pinnacle 21 validation and AI tools for programming efficiency.
• Ability to create Define.xml and submission packages.