Sr & Pr Statistical Programmer

Sigma-Chiconsulting; Hyderabad, Visakhapatnam; Hybrid; INR 3,500,000 - 5,500,000; Full time

Benefits offered by this job

Global programs

AI TLF QC tools exposure

Hybrid + home-based working

Career growth

Job summary

Sigma-Chi Consulting in Hyderabad/Visakhapatnam is seeking a Senior/Principal Statistical Programmer to lead programming on complex studies and regulatory submissions, guiding a team of programmers and serving as the technical point of contact for sponsors.

The role requires 7+ years SAS programming in clinical research (10+ for Principal), strong CDISC SDTM/ADaM/Define-XML expertise, and excellent English.

Qualifications

• Degree in Statistics, Mathematics, Computer Science, Life Sciences or 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.

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 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 standards, macros and SOPs.

Skills

SAS programming

English communication

Education

Statistics/Math/CS/Life Sciences degree

Tools

CDISC SDTM

ADaM

Define-XML

Job description

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