Work as a principal programmer across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.
The role will be full time and fully remote, the successful candidate will be based in
India
. The successful candidate's working hours will overlap with
US working hours.
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
- The ability to create, validate and maintain CDISC SDTM and ADaM datasets in compliance with regulatory submissions
- Proficiency in SAS (Macros, Base, Graphs) and other statistical Programming tools
- Experience with Define.xml, Reviewer’s Guide (SDRG, ADRG) and regulatory compliance documentation
- Relevant leadership experience
- Familiarity and experience with SDTM/ADaMs and TLFs
- Experience working on Integrated Summaries (ISS/ISE)
- At least 7 years of CDISC and Clinical trials experience
- eCRT experience is a must
Why Join Us
- Remote working and flexible working hours
- Career development, mentorship, and continuous learning
- Supportive, friendly, and collaborative culture
About Phastar
Phastar is an award-wi
📌 Principal Programmer (India)
🏢 PHASTAR
📍 India