Overview:
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.
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Adhere to client SOPs and work on client systems
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Oversight of Vendor Programming
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Knowledge of FDA CRT requirements including define.xml and define.pdf
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Lead team and be responsible for creation of CRT packages
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Become independent technical expert
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Program complex non efficacy outputs/ figures
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Perform Senior Review and Deliver QC of non- statistical output
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Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
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Validate and perform User Acceptance Testing (UAT) on standard macros
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Identify macros requirements, communicate and perform training
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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
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Good awareness of clinical trial issues, design, and implementation
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In-depth knowledge of SDTM, including but not limited to controlled terminology
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Experience in ECRT package preparation (aCRF, Define.xml, cSDRG)
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Strong programming skills
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Ability to lead projects and work independently
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Strong SAS programming and clinical trial experience
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Prior experience in RWD projects is preferred but not essential.
Apply Now!
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.
Apply today!
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