About Sigma-Chi Consulting
With more than a decade of experience, Sigma-Chi Consulting is a trusted biometrics partner to pharmaceutical and biotech sponsors, with teams in Hyderabad and Visakhapatnam supporting clients in the USA and Europe. We deliver biostatistics, statistical programming, clinical data management and AI-driven TLF quality control, with a strong focus on quality and on-time delivery.
Location: Hyderabad / Visakhapatnam, India (hybrid or home-based)
Job Overview
As a Senior / Principal Statistical Programmer you will lead programming on complex studies and submissions, guide a team of programmers and act as the technical point of contact for our sponsors.
Key Responsibilities
- Lead SDTM, ADaM and TLF programming for one or more studies or an integrated submission (ISS/ISE)
- Set the programming strategy, timelines and resourcing for your projects
- Review specifications, programs and outputs written by other programmers
- Contribute to statistical analysis plans, mock shells and dataset specifications
- Prepare submission packages: Define-XML, reviewer guides (SDRG/ADRG) and Pinnacle 21 reports
- Track project progress and quality metrics, and communicate status to sponsors
- Mentor junior programmers and help improve our standards, macros and SOPs
Requirements
- Degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field
- 7+ years of SAS programming in clinical research (Principal: 10+ years)
- Strong hands-on knowledge of CDISC SDTM, ADaM and Define-XML
- Experience leading studies and supporting regulatory submissions
- Clear written and spoken English and confidence working with global sponsors
Good to have
- R programming (tidyverse, admiral) for clinical outputs
- Oncology, CNS or vaccine study experience
- Experience with automated QC or validation tooling
What we offer
- Lead roles on global pharma and biotech programs
- Exposure to our in-house AI TLF QC tools
- Flexible hybrid and home-based working
- A collaborative team with clear career growth paths
How to apply
Use the Quick Apply button on this page, or send your CV to hr@sigma-chiconsulting.com with the job title in the subject line.