Principal statistical programmer (Kanpur)

Cytel; Kanpur; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cytel is sponsoring a dedicated Principal Statistical Programmer role working closely with one of our global pharmaceutical clients. The role focuses on implementing reporting and analysis activities for sponsor trials, delivering SDTM/ADaM datasets, and managing CRO programming deliverables.

The successful candidate will be a senior programmer who can work independently with minimal supervision, contributing to data summaries, tables, listings, and figures for regulatory submissions across

Qualifications

• Senior statistical programmer with clinical development experience.
• Expertise in SAS and R for programming, analysis, and reporting.
• Experience delivering SDTM/ADaM datasets and specifications.
• Ability to oversee CRO programming deliverables and ensure quality, timelines.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and complex graphs
• Deliver high-quality statistical programming outputs and maintain SAS/R programs
• Oversee CRO programmers to ensure high quality and timely delivery across studies
• Support preparation of clinical study reports and regulatory submissions

Skills

SAS programming

R programming

SDTM/ADaM specifications

Statistical programming

Data listings & tables

Tools

SAS

R

Job description

Sponsor-dedicated

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer, you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this recent program.

Position Overview

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision; tracks progress and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

Responsibilities

• Generate SDTM, ADa M specifications, datasets, reviewers guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs
• Participate in overseeing CROs statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory su .