Principal/Senior- Statistical Programmer

About the job Principal /Senior -Statistical Programmer -Remote India As an experienced programmer, you will hold a combined project leadership and hands-on technical statistics role. Working across a defined area within the sponsor team you will be leading studies and working on sponsor systems

Responsibilities Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Adhere to client SOPs and work on client systems Oversight of Vendor Programming Knowledge of FDA CRT requirements including define.xml and define.pdf Lead team and be responsible for creation of CRT packages Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Identify macros requirements, communicate and perform training Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.

Qualifications

Educated to BSc or above within Computer Science, Mathematics or a Science related discipline Good awareness of clinical trial issues, design, and implementation In-depth knowledge of SDTM, including but not limited to controlled terminology Experience in ECRT package preparation (aCRF, Define.xml, cSDRG) Strong programming skills Ability to lead projects and work independently Strong SAS programming and clinical trial experience Prior experience in RWD projects is preferred but not essential.

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Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities.

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