Director of Biostatistics - Lead Strategic Clinical Trials
Bristol-Myers Squibb
- # Director, BiostatisticsMadison - Giralda - NJ - US**Working with Us**Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.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. Read more: .At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, cell therapy, immunology, cardiovascular and neuroscience 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 SummaryDirector of Biostatistics is a core member of the cross-functional development team, leading the statistical strategy in development of compounds within a therapeutic area. Drives design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access. Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses. Provides guidance and oversight to statisticians to ensure high quality and timely deliverables. Manages resources, sets priorities, and ensures consistency and adherence to standards therein.Key Responsibilities* Drives innovative and efficient study design. Develops study designs that address study objectives that will support regulatory approval, medical research and market access.* Independently leads, initiates, and oversees the statistical support for the development of compounds within a therapeutic area* Provides guidance and oversight to statisticians to ensure high quality and timely deliverables.* Effectively engages as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process* Presents and defends complex statistical solutions to all levels of BMS governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions* Contributes to Clinical Development Plans, leads GBDS related submission activities, and post-submission strategies/ preparations/defenses.* Provides statistical support and leadership to address health authority requests, publication, presentation, and other public release of information.* Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable* Contributes to creation/maintenance of and provide training on statistical topics departmental SOPs.* Manages a functional or project budget, and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.* Represents BMS at professional societies, and in industry-wide technical discussions.* Contributes to the statistical community of practice* Provides active coaching to statistical team members when developing solutions to problems.* Effectively communicates the DQS Mission and Vision in a fashion that generates pride, excitement and commitment within DQS.* Fosters a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.Applicable to people managers* Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally* Provides leadership to empower and develop the team.* Provides guidance to employee's development plans and carries out performance review and feedback. Develops performance metrics for staff.Qualifications & Experience* PhD (9+ years experience) or MS (11+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience,* Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.* Excellent interpersonal, communication, writing and organizational skills* Demonstrate expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.* Experience in preparing and participating in global regulatory agency interactions* Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills* Demonstrate development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area.* At least 3 years management (direct or matrix) experience is preferred (for people manager position only)**Why You Should Apply**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.*If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.*******Compensation Overview:******Madison - Giralda - NJ - US: $218,740 - $265,060Princeton - NJ - US: $218,740 - $265,060The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visitBenefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:* **Health Coverage:** Medical, pharmacy, dental, and vision care.* **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).* **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support,
- J-18808-Ljbffr Bristol-Myers Squibb
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