Overview
Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.
This role is full-time and fully-remote. The successful candidate may be based in India.
Responsibilities
The following areas of expertise will be aligned to the role...
• Statistical expertise and scientific leadership
• Leadership and people development
• Compliance, quality and governance
• Communication and influence
Qualifications
• BSc in Mathematics, Computer Science or a related discipline.
• Robust experience in clinical trial statistics and SAS programming,
supporting Phase II/III studies across analysis, reporting, and regulatory submission activities.
• Hands-on expertise in SDTM, ADaM, TLF development and validation, with strong knowledge of CDISC standards and submission-ready deliverables.
• The successful candidate will have experience supporting regulatory submissions, including NDA/BLA, MAA, ISS/ISE, eCTD packages, define.xml, reviewers’ guides, and responding to regulatory authority queries.
• The ability to interpret protocols, SAPs, shells, and statistical specifications, translate requirements into high-quality analysis outputs, and identify issues proactively.
• Strong understanding of submission QC, traceability, data integrity, and programming best practices, including independent validation, macro usage, documentation, and adherence to SOPs.
• Proven ability to work independently with statisticians, programmers, data management, medical writing, and sponsor teams, manage ti
📌 Principal Programmer (India)
🏢 PHASTAR
📍 India