Principal Statistical Programmer FSP

Cytel; India; On-site; INR 1,200,000 - 1,500,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded within a pharmaceutical client, providing expertise to drive innovation in patient treatment. In this role, you will generate statistical datasets and oversee the quality of deliverables from CROs across multiple clinical studies.

The ideal candidate has a bachelor's degree and 7+ years of experience in statistical programming within the biotech or pharma sector. Strong SAS skills and familiarity with regulatory submissions are key to succeed in this position.

Qualifications

• 7+ years of experience as a statistical programmer in clinical development.
• Exceptional SAS programming skills and statistical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM).

Responsibilities

• Generate SDTM, ADaM specifications, datasets, and other outputs for studies.
• Develop SAS programs for datasets and statistical outputs.
• Oversee CRO programming deliverables for clinical studies.

Skills

SAS programming

Statistical analysis

Regulatory submission experience

Communication skills

Leadership skills

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Job description

Working fully embedded within a pharmaceutical client, with the support of Cytel, you will be at the heart of the client’s innovation. As a Principal Statistical Programmer, you will dedicate your expertise to a global pharmaceutical company driving the next generation of patient treatment. This is an exciting time to be part of this program.

Position Overview

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit. The Principal Statistical Programmer works independently, tracks progress, and provides expert technical support to team members. You will work on clinical development programs across therapeutic areas and oversee CRO programmers to ensure data summaries are delivered consistently and with high quality. You will be responsible for implementing all reporting and analysis activities for sponsor clinical trials.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs that generate datasets, complex listings, tables (including 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 program needs
• Oversee CRO statistical programming deliverables for multiple clinical studies to ensure high quality and adherence to pre‑specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and apply FDA regulations affecting reporting of clinical trial data, including good clinical practice and electronic submission guidelines
• Contribute to creation, maintenance, documentation, and validation of programming standards, tools, outputs, and macros
• Participate in development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g., CROs, software vendors, clinical development partners) to meet project timelines and goals
• Provide review and/or author SOPs and/ or work instructions related to statistical programming practices

Qualifications

• Minimum bachelor’s degree in computer science, data science, mathematics, or statistics (major preferred)
• 7+ years of experience as a statistical programmer on a biotech/Pharma clinical development biometrics team or a similar team, supporting drug development, medical device development, or intervention studies
• Exceptional SAS programming skills and expertise in developing and implementing statistical programming procedures and processes in a clinical development environment
• Extensive applied experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
• Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities
• Ability to work independently
• Outstanding written and verbal communication skills and strong leadership skills

Preferred Qualifications

• Prior work experience with pharmacokinetic data and the neuroscience field
• Proficiency in languages or tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, and Git)