Manager - Statistical Programming
On-siteHyderabad, Telangana, India
Job Summary
Develop programming strategies, standards, and specifications for clinical project teams to support product development, regulatory approval, and market acceptance. Design, develop, and implement technical solutions for integrating, analyzing, and reporting clinical data while collaborating with cross-functional teams, external vendors, and DQS leadership. Review planning documents to ensure alignment with development objectives and provide technical guidance to vendors for analysis and reporting work. Apply A&R standards and regulatory requirements to ensure quality of deliverables, identify process improvement opportunities, and contribute to the standardization of tools and processes.
Required Qualifications
- 5 - 8 years clinical/statistical programming experience within pharmaceutical clinical development
- Undergraduate or Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience
- Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as related to clinical drug development
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements
- Ability to work successfully within cross-functional teams leads to successful global regulatory filings and approvals
- Ability to be flexible and adapt quickly to the changing needs of the organization
- Ability to organize multiple work assignments and establish priorities
- Excellent verbal and written communications skills
- Site-essential roles require 100% of shifts onsite at your assigned facility
- If you live in or expect to work from Los Angeles County if hired for this position
Desired Qualifications
- Oncology Experience preferred
- Master's degree preferred
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