Functional Goal:

Serve as the Sponsor's accountable Statistical Programming representative, ensuring that all statistical programming activities are conducted in compliance with ICH, GCP, regulatory requirements, and company standards, whether performed internally or outsourced to external partners. Provide strategic insight and operational statistical programming expertise across the entire clinical development lifecycle, from study start-up through regulatory submission, approval, and post-submission support.

Support the development, implementation, maintenance, and continuous improvement of statistical programming processes, standards, key performance indicators (KPIs), and cutting-edge technologies, including automation solutions that enhance quality, efficiency, and compliance. Contribute to the governance, maintenance, and optimization of clinical data repositories and analysis platform(s), and data exchange tools to support reliable, traceable, and efficient clinical data management and analysis across development programs.

Main TAsks:
- Ensure completeness,



correctness and consistency of clinical programming deliverables in all assigned clinical studies/programs to achieve high quality results in agreement with defined specifications and timelines
- Propose standardization and automation of programming related tasks in collaboration with Biostatistics, Data Management and other clinical functions to improve consistency and efficiency of information management across biosimilars programs.
- Maintain up to date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC). Track emerging trends and apply them to improve programming support across all biosimilars programs.
- Review CRFs/eCRFs and data management specifications documents; Statistical Analysis Plans/mock TLFs.
- Lead data package preparation for electronic submissions. Review of CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewers guide

📌 Senior Statistical Programming Consultant (Pune)
🏢 Gi Group
📍 Pune