4 - 9 years
7 - 17 Lacs
Posted:14 hours ago|
Platform:
Work from Office
Full Time
We are seeking an experienced and driven Senior Lead Statistical Programmer with 1015 years of experience in clinical trial programming to join our growing team. The ideal candidate will have deep expertise in SAS, CDISC standards (SDTM & ADaM), and TFL generation, with strong exposure to regulatory submissions and integrated analyses across therapeutic areas such as oncology, neuroscience, and immunology.
Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level
Design and develop SDTM and ADaM datasets as per CDISC standards
Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions
Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides
Provide technical leadership and mentorship to global programming teams
Collaborate closely with biostatistics, data management, and regulatory affairs teams
Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects
Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards
Bachelors or Masters degree in Statistics, Computer Science, or a related field
10+ years of SAS programming experience in clinical research or pharmaceutical industry
Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis
Creation and validation of ISS and ISE reports
Deep understanding of CDISC standards, regulatory compliance, and submission requirements
Prior experience in oncology, neuroscience, or immunology domains preferred
Proven leadership capabilities in managing cross-functional and global teams
Excellent communication, project management, and problem-solving skills
SAS (Base, Macro, STAT, Graph)
Creation and validation of ISS and ISE reports
Familiarity with SDTM/ADaM IG, FDA submission standards
Creation and validation of ISS and ISE reports
Understanding of regulatory submission formats (eCTD)
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