Principal Biostatistician

Profile

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.

POSITION Principal Statistician

SUPERVISOR Associate Director or Director Statistician

DEPARTMENT Biometrics and Data Operations

PREREQUISITES


Ph.D. in Statistics with 5 plus years or MS with 7 plus years pharmaceutical experience as a statistician supporting clinical trials.


Responsibilities will include, but are not limited to, the following:


Actively provide statistical support to the Clinical R&D Department.

Provide statistical input into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs that are acceptable by regulators.

Prepare statistical analysis plans including table shells.

Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc/data driven analyses.

Provide statistical input for the preparation of final study reports and other required documents.

Provide statistical support for integrated reports, submissions preparation, and postsubmission activities.

Contribute to Clinical Development Plan.

Support preparation of manuscripts.

Provide project requirements to programmers.

Serve as statistical lead on studies, projects, NDAs or sNDAs.

Represent Bristol Myers Squibb in interfaces with regulatory agencies globally.

Provide statistical input to senior management.

Manage outside CROs and consultants as needed.

Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.

Provides leadership

Sought out statistical expert to peers and others

Provides supportive feedback to peers and leaders

Proactively seeks ways to gain broader experience/perspectives and make contributions

Participates in cross-functional collaboration and meetings to gain the trust and respect of members, make decisions on business issues and freely challenges and expresses opinions

May provide coaching and mentoring and provides feedback via formal/informal appraisals


Skills/Knowledge Required:


Ph.D. or MS in statistics with a focus on statistical methods appropriate for clinical trials.

Experience in clinical drug development of at least 5 years for Ph.D. and 7 years for MS.

Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.

Demonstrated skill in the planning, analysis and reporting of clinical trials. .

Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.

Excellent SAS skills.. Willingness to be hands-on when needed.

Knowledge of MS Office products (Word, Excel, PowerPoint)

Good interpersonal, communication, writing and organizational skills.

Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.


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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

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