Principal/Senior- Statistical Programmer

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

• 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.

• 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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