Associate Director, TA Analysis Standards Leader
4 weeks ago
As a key member of the Bristol-Myers Squibb Company team, the Associate Director, TA Analysis Standards Leader will play a crucial role in developing and promoting the strategy and infrastructure for creation, maintenance, and implementation of analysis standards across the Therapeutic Area. This position requires a strong understanding of analysis standards, clinical trial methodology, and regulatory guidance. The ideal candidate will have a proven track record of leading improvement initiatives and driving end-to-end standards.
Key Responsibilities
- Develops Analysis Standards strategy for assigned therapeutic area in collaboration with key stakeholders utilizing risk-based approaches and differentiating early clinical development and late phase strategies.
- Leads implementation of analysis standards practices across the value chain, and utilizes standards adherence metrics to showcase value.
- Ensures consistent approach to implementation and governance of clinical analysis standards across Therapeutic areas in partnership with the Head of Analysis Standards Governance.
- Accountable for overall adherence to analysis standards industry regulations and guidance while maintaining emphasis on exceptional analysis quality.
- Act as expert consultant for escalated issues for TA level analysis standards.
Requirements
- Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required.
- At least 10 years programming experience in industry including support of significant regulatory filings and extensive knowledge of analysis standards.
- Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
- Broad expertise in statistical programming and in developing computing strategies.
- In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.
Preferred Requirements
- Member of industry organizations or presented at Congresses/Conferences.
- Immunology Therapeutic Experience.
About Us
Bristol-Myers Squibb Company is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to creating a diverse and inclusive work environment that promotes growth and development for all employees. If you are passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career, we encourage you to apply.
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