- Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures on new assignments. Exercises judgment in selecting methods, evaluating, adapting of complex techniques and evaluation criteria for obtaining results.
- Work independently as lead statistical programmers on several different projects while being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables
- Be a Therapeutic Area expert solution provider, guide & mentor statistical programmers to develop and manage high performing teams
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
- Generating, validating, reviewing SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs)
- Production and QC / validation programming
- Generating complex ad-hoc reports utilizing raw data
- Applying strong understanding/experience of Efficacy analysis
- Generating, validating, reviewing submission packages
- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
- Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically.
- Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
- Provide advanced technical expertise in conjunction with internal and external clients and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
- Compliance to regulatory requirements
- 14.Commitment to compliance with Integrated management system which includes standards like ISO 9001, 27001, 22301 and any new standards that the organization plans to implement.
- 15.Participate in the trainings organized for these applicable standards.
Job Types: Full-time, Permanent
Pay: ₹4,000,000.00 - ₹4,500,000.00 per year
Benefits:
- Cell phone reimbursement
- Health insurance
- Paid sick time
- Provident Fund
- Work from home
Work Location: Remote