VI
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About the role
- Oversee the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance.
- Serve as the point of escalation to ensure the timeliness and accuracy of Biometric deliverables.
- Drive development and adherence to Biometric vision, strategy, and operational excellence for global development programs.
- Anticipate new challenges, risks, and needs for the department, and proactively mitigate to ensure business continuity.
- Oversee performance of external vendors responsible for clinical data deliverables to ensure quality completion of all clinical data related deliverables.
- Ensure expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally and externally.
- Lead development of new / streamlining procedures and process improvement to meet the needs of an evolving Biometrics Department.
- Collaborate with partner functions to provide statistical programming, systems analysis, and database management support for important Clinical Development deliverables.
- Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements.
- Ensure compliance with Clinical Data Interchange Standards Consortium (CDISC) standards to ensure high data quality standards.
Requirements
- Master's degree or higher in Statistics/Biostatistics area
- 8+ years of experience in pharma/biotech industry, with in-depth knowledge of Data Management and Biostatistics processes
- 3+ years of experience in managing a team, including responsibility for projects as well as hiring, managing, mentoring, and/or developing direct reports.
- Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
- Strong working knowledge of Biostatistics processes
- Experience in managing an outsourced data management model.
- Extensive experience with Medidata RAVE and other industry EDC platforms
- Extensive knowledge with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
- Familiarity with CDASH and SDTM standards
Benefits
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
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