Posted:1 week ago|
Platform:
Work from Office
Full Time
Role: Senior Consultant - Clinical Programming Location: Pune Work Mode: Hybrid (4 Days WFO and 1 Day WFH) Experience: 10+ Years Key responsibilities include: Oversight of outsourced programming deliverables Maintain up to date advanced knowledge of programming software (e.g SAS) as well as industry requirements (e.g CDISC). Development and validation of SAS programs for analysis Review of study documentation (CRFs, SAPs, mock TLFs) Review CRFs/eCRFs and data management specifications documents; Statistical Analysis Plans/mock TLFs. Preparation of CDISC-compliant submission packages Lead data package preparation for electronic submissions. Review of CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewers guides, SAS programs...) Support during audits and regulatory inspections Automation, standardization, and process improvement Mentoring junior programmers and supporting internal tools and KPIs Requirements: 10+ years of experience in clinical programming, strong SAS expertise, knowledge of CDISC standards, regulatory submission experience, and CRO oversight. This role demands strong technical, organizational, and communication skills, with the ability to work in a global, fast-paced environment.
Medulla Recruitment Services
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Recruitment & Staffing
50-100 Employees
3 Jobs
Key People
20.0 - 35.0 Lacs P.A.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
25.0 - 30.0 Lacs P.A.