Senior Statistical Programmer, FSP — SDTM/ADaM Expert

Cytel; India (PA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor project within a pharmaceutical client environment. You will implement all reporting and analysis activities for Sponsor trials, collaborating with internal and CRO teams to deliver high-quality outputs with autonomy and ownership.

The role requires extensive SAS programming experience, CDISC standards expertise, and a track record of contributing to regulatory submissions.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team.
• Exceptional SAS programming skills for clinical development environments.
• Extensive experience with CDISC standards (SDTM/ADaM/Define.xml) and regulatory requirements.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead teams; strong written and verbal communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and complex graphs.
• Deliver high-quality programming outputs and maintain SAS/R code for clinical programs.
• Oversee CRO programmers and ensure timely, high-quality deliverables.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Ensure compliance with FDA regulations and GCP for reporting.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; review external data transfers.
• Collaborate with CROs, vendors, and internal teams to meet timelines.

Skills

SAS programming

CDISC SDTM/ADaM

R and Python

Independent work

Leadership and communication

Education

B.S. in CS/Data Science/Math/Stats

Tools

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor project within a pharmaceutical client environment. You will implement all reporting and analysis activities for Sponsor trials, collaborating with internal and CRO teams to deliver high-quality outputs with autonomy and ownership.

The role requires extensive SAS programming experience, CDISC standards expertise, and a track record of contributing to regulatory submissions.