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.
- 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.
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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