Statistical Programmer
2 weeks ago
Job Location – Pune
Experience Range – 4 to 7 Years
Skillset Required- Knowledge of medical device risk classification
Interested candidates are requested share updated CV with below details on the mail id – Babeeta.shahi@tcs.com
1. Work collaboratively with team members on a daily basis
2. Participate in team meetings
3. Independently work directly with Data Management Lead to gather requirements, including F2F/ video conferences
4. Translate requirements to design, program and execute SAS codes to analyze, graph, derive and report analytical data for regulatory submissions
5. Develop SAS edit checks for data cleaning/derivation
6. Base on scientific and compliance principles in data derivation/transformation
7. Extracting and merging data to generate standard CMC eCTD data tables, adhering to group standards
8. Performing ad-hoc data reporting e.g. statistical analyses, metrics, plots
9. Perform standard statistical analyses for shelf-life estimation
10. Provide draft output within 24 hours for internal review
11. Provide documentation of programs and projects adhering to regulatory and company standards
12. Manage multiple projects with overlapping timelines and deliverables simultaneously
13. Escalate issues to Project Lead directly and timely (within 1 day)
14. Timely completion of all required training
Adhere to SOPs and GMP regulations
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