Principal Programmer

Job Summary

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 candidates 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

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