Sr Statistical Programmer

Job Summary

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.
• Strong 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 timelines, communicate risks early, and deliver high-quality outputs under tight submission deadlines.
• MSc in Mathematics, Computer Science or a related discipline is advantageous.

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