Associate Director, TA Analysis Standards Leader

3 days ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Transforming Patients' Lives through Science

Bristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced 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.
  • 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.
Requirements:
  • 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, including implementing process change internally and at a vendor.
  • Demonstrated ability to influence without authority.
  • Excellent written and oral communication skills.
Preferred Requirements:
  • 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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