Associate Director, Biostatistics

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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

The Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.

Primary Responsibilities

• Core member of an EDT and key sub-teams. Contributes to all aspects of the development strategy.

• Independently leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.

• Participates in development strategy, protocols and analysis plans reviews.

• Participates in continuous improvement initiatives.

• Invests in knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development teams.

• Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.

• Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.

• Possesses technical knowledge of statistical methodology and ability to appropriately apply it in trial design and data analysis for clear, concise, high-quality results.

• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.

Education/Experience

• PhD degree in Statistics or Biostatistics or Master’s degree with 7+ years' of relevant Pharmaceutical/R&D or other related experience, including supporting regulatory filings.

• Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.

• Relevant prior data analysis planning, execution and delivery experience.

• Excellent verbal and written communications skills.

• Ability to be flexible and adapt quickly to the changing needs of the organization.

• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement, including the resolution of conflicts or their appropriate escalation

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