Associate Director Biostatistics
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position: Associate Director Biostatistics
Reports to: Director, Biostatistics
Direct Reports: Yes
Location: San Diego, CA or Berkeley Heights, NJ
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Responsible for collaborating with clinicians and biostatistics management on statistical strategy for study teams within Celgene Inflammation & Immunology. Serves as primary biostatistician on multiple studies and oversees the work of CRO. Contributes to late phase Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses.
Responsibilities and Duties include, but not limited to:
- Contributes to Clinical Development Plans, submissions and post-submission strategies, preparations and defense, ensuring quality and timing thereof;
- Participate in study design and protocol development;
- Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios;
- Propose methods for statistical analysis and draft the statistical sections of study protocols, with the ability to work on innovative statistics methodologies or clinical trial designs for drug discovery.
- Perform simulations to assess various study design options and analysis approaches;
- Review and consult on CRF design and database edit checks;
- Prepare randomization schedules;
- Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Review programming and analysis specifications and oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data;
- Lead the study and/or project teams in the review, and discussion, of analysis plans;
- Interpret statistical results and present study findings to the teams, senior management, and in various external forums;
- Participate in organizing and writing results for primary publication; Provides statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned;
- Maintain project files that ensure adequate and clear documentation of statistical analyses;
- Contributes to, and provides training on new departmental statistical topics, SOPs, WPs;
- Impacts directly on overall business and Biostatistics performance through the ability to influence and work in a consultative manner with senior stakeholders;
- Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation;
- Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.
Knowledge, Skills, Abilities and Qualification Requirements:
- Ph.D. in statistics, biostatistics (or related field);
- 8+ years of prior experience in a drug-development environment (Level will be commensurate with experience);
- Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional;
- Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards;
- Advanced applicational use with SAS and/ or other relevant statistical software to support optimal planning and analysis of clinical trials/ development programs;
- Keeping abreast of regulatory guidance for relevant indications within a TA;
- Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel;
- Experience writing technical documents, reports, and presentations;
- Ability to manage multiple and diverse issues;
- Professionalism and customer service orientation;
- Communication skills - written and verbal;
- Planning, organizing and multi-tasking;
- Prioritizing and time management;
- Problem assessment and problem solving;
- Information gathering and information monitoring;
- Attention to detail and accuracy;
- Flexibility, adaptability and teamwork;
- Demonstrated strong leadership, project management, teamwork, and interpersonal skills;
- Knowledge in computational statistics, Bayesian methodology, innovative study design or R-Shinny is desirable;
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Back to top