Associate Director, TA Analysis Standards Leader
1 week ago
Bristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an exceptional Associate Director, TA Analysis Standards Leader to join our team.
Key Responsibilities:- Develop and promote the strategy and infrastructure for creation, maintenance, and implementation of analysis standards across the Therapeutic Area.
- Align cross-functionally and drive end-to-end standards to ensure consistency and quality.
- Lead improvement initiatives under the sponsoring of Therapeutic Area Head or Statistical Programming leadership team.
- Proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate development and implementation of Analysis Standards.
- Manage the change management process, including communication, training, and stakeholder engagement.
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
- At least 10 years of 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 developing computing strategies.
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases.
- Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS office, XML, Pinnacle 21).
- Demonstrated ability to work in a team environment with clinical team members.
- Demonstrated ability to establish effective business relationships with internal and external stakeholders.
- Demonstrated ability to influence without authority.
- Excellent written and oral communication skills.
- Member of industry organizations or presented at Congresses/Conferences.
- Immunology Therapeutic Experience.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Princeton, New Jersey, United States Bristol-Myers Squibb Company Full timeJob SummaryBristol-Myers Squibb is seeking a highly skilled Associate Director, TA Analysis Standards Leader to join our team. This role is responsible for developing and promoting the strategy and infrastructure for creation, maintenance, and implementation of analysis standards across the Therapeutic Area.Key ResponsibilitiesDevelop and implement analysis...
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Princeton, New Jersey, United States Bristol-Myers Squibb Company Full timeTransforming Patients' Lives through ScienceBristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Associate Director, TA Analysis Standards Leader to join our team.Key Responsibilities:Develop and promote the strategy and infrastructure for creation,...
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