Principal Statistical Programmer

Emmes; Bengaluru; Sur place; INR 2 500 000 - 3 800 000; Plein temps

Résumé du poste

Emmes Group is seeking a Principal Statistical Programmer to lead the design, development, and validation of statistical programming deliverables for clinical trials and regulatory submissions. You will serve as a technical expert on study teams, ensuring standards compliance and high-quality outputs.

You will mentor junior programmers, collaborate with Biostatistics, Data Management, and Clinical teams, and drive submission-ready datasets and documents (define.xml, reviewer guides).

Qualifications

• Bachelor's or Master's degree in Computer Science, Statistics, Life Sciences, or related field.
• 7-9 years of statistical programming experience in pharma/biotech/CRO.
• Expert level proficiency in SAS Base, SAS Macro, and SAS SQL.
• In depth experience with CDISC SDTM and ADaM standards.
• Proven track record supporting clinical trial reporting and regulatory submissions.
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA/EMA expectations.
• Excellent problem solving skills and attention to detail.
• Strong communication and collaboration skills.

Responsabilités

• Lead the design, development, validation, and maintenance of statistical programming deliverables for trials and submissions.
• Serve as lead programmer on multiple studies, coordinating with internal teams and CROs.
• Provide technical oversight and mentorship to junior programmers and contractors.
• Ensure deliverables comply with CDISC, FDA/EMA standards and internal SOPs.
• Prepare submission-ready datasets, define.xml, and reviewer guides for regulatory authorities.
• Support ISS/ISE analyses and integration into NDA/BLA/MAA submissions.

Connaissances

SAS programming

Regulatory submissions

Analytical mindset

Attention to detail

Communication

Formation

Bachelor's or Master's in Computer Science/Statistics/Life Sciences

Outils

SAS Base

SAS Macro

SAS SQL

CDISC SDTM/ADaM

Pinnacle 21/OpenCDISC/define.xml

Description du poste

Overview

Principal Statistical Programmer

Be Part of One Team, One Purpose.

At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.

We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.

The Principal Statistical Programmer is a senior-level contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions. This individual serves as a technical expert on study and project teams, providing leadership in the application of statistical programming standards and regulatory guidance (e.g., CDISC, ICH, FDA).

Responsibilities

• Technical Programming Leadership
• Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
• Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions.
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code.
• Project & Study Support
• Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Collaborate closely with Biostatistics, Data Management, and Clinical teams to deliver timely and accurate outputs.
• Standards & Compliance
• Ensure programming deliverables comply with industry standards (CDISC, FDA, EMA) and internal SOPs.
• Contribute to the development and implementation of programming standards and reusable code libraries.
• Participate in quality control, peer review, and validation of programming deliverables.
• Submission & Regulatory Support
• Prepare and review submission ready datasets, define.xml files, and reviewer guides for regulatory authorities (e.g., FDA, EMA).
• Support integrated summaries of safety (ISS) and efficacy (ISE) analyses for NDA/BLA/MAA submissions.
• Use tools such as Pinnacle 21, OpenCDISC, and define.xml generators to ensure submission compliance.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field. Required or
• 7-9 years in statistical programming within the pharmaceutical, biotech, or CRO industry. Required
• Expert level proficiency in SAS Base, SAS Macro, and SAS SQL. High
• In depth experience with CDISC SDTM and ADaM standards. High
• Proven track record of supporting clinical trial reporting and regulatory submissions. High
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA and EMA regulatory expectations. High
• Excellent problem solving skills and attention to detail. High
• Strong communication and collaboration skills. High

If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.

CONNECT WITH US!

Find us on LinkedIn:/the-emmes-group/

Visit our website: https://www.theemmesgroup.com/