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Mid-level experience and Bengaluru location increase competition, while clinical/SAS niche reduces applicant pool.
Clinical programming, CDISC and regulatory expertise limit cross-industry transferability and raise background sensitivity.
Specific SAS/CDISC certification, regulatory/NDA experience and explicit years requirement make shortlisting highly selective.
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Develop, validate, and deliver SDTM and ADaM datasets, TLFs, and submission-ready statistical outputs for multiple clinical studies following regulatory standards (FDA, EMA, PMDA).
Design and maintain reusable SAS macros and implement data automation using SAS and R programming with AI tools to improve efficiency.
Collaborate across teams to ensure timely, accurate, and compliant clinical study deliverables aligned with industry and eClinical guidelines.
4-5 years of experience in Pharmaceutical/Biotechnology or equivalent IT consulting role, with strong experience in NDA filing preparations.
Proficiency in SAS programming including Base SAS, SAS/STAT, Macro Language, PROC SQL, PROC REPORT, PROC SUMMARY, PROC FREQ, and PROC TRANSPOSE.
Knowledge and experience with CDISC standards (SDTM, ADaM) and regulatory compliance (FDA, PMDA, EMA), including coding dictionaries like MedDRA.
Bachelor of Science degree in health-related fields, computer science or equivalent; SAS certification required; R programming experience and AI tool use are plus.
Experienced in handling multiple clinical protocols and delivering datasets and TLFs for clinical trials from Phase I to IV with regulatory submissions.
Technical expertise in advanced SAS programming, performance optimization, data automation, and R programming within clinical research environments.
Demonstrated ability to create and maintain reusable programming macros and leverage AI tools to enhance programming efficiencies.