Associate Director, Nonclinical Biostatistics

Company: Bristol Myers Squibb
Location: Berkeley Heights
Posted on: May 28, 2023

Job Description:

**Working with Us**
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: careers.bms.com/working-with-us .
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, cell therapy, immunology, neuroscience and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contributes to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
**Position Summary**
The Associate Director, Nonclinical Biostatistics, is a member of cross-functional teams, provides leadership for both bioanalytical assay development and drug safety studies. Contributions in the bioanalytical area include the optimization, validation, and troubleshooting of immunogenicity (IMG), biomarker, and pharmacokinetic (PK) assays. Contributions in the drug safety area include reviewing and improving study protocols; analyzing data for general toxicology studies on an as-needed basis; assisting with the development and validation of PK, biomarker, IMG and genotoxicity assays; and analyzing tumor and mortality data from carcinogenicity studies. This individual develops collaborative relationships and works effectively with non-clinical scientists, and other cross-functional team members.
**Key Responsibilities**
+ The Associate Director leads the planning and execution of statistical strategies for nonclinical and clinical bioanalytical assay development. This includes: contributions to study design and protocol development; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring internal study reports, regulatory submissions, and publications. Provides immediate troubleshooting for failing assays.
+ The Associate Director leads the planning and execution of statistical strategies for both GLP and non-GLP drug safety studies. These include: contributions to study design and protocol review; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring reports, regulatory submissions, and publications. Animal safety assessment areas include: general toxicology (including pathology), immunotoxicology, genetic toxicology, and carcinogenicity studies.
+ Provides statistical education and training to scientists.
+ Expeditiously addresses queries from regulatory agencies with high quality responses.
+ Presents the results of statistical analyses, their interpretation, and conclusions, to scientists and management in a clear, concise, complete, and transparent manner.
+ Contributes to external and internal statistical community of innovation and practices
**Qualifications/Experience**
+ PhD (6+ years experience) or MS (8+ years experience) in statistics or biostatistics or related scientific field with relevant Pharmaceutical R&D or other related experience.
+ Demonstrated knowledge of statistical methodology specific to assay development and drug safety studies.
+ Possesses technical knowledge of broader statistical methodology, and ability to appropriately apply it in design and statistical analysis for accurate and high-quality results.
+ Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
+ Great communication, writing and organizational skills.
+ Good understanding of regulatory landscape and experience with participating in regulatory interactions
+ Demonstrates collaboration, organizational/ leadership abilities, and interpersonal skills
+ Demonstrates ability to plan, organize, and prioritize multiple work assignments, and strong project management skills
_If you come across a role that intrigues you but doesnt 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._
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol Myers Squibb
**Req Number:** R1568819
**Updated:** 2023-05-24 00:51:10.609 UTC
**Location:** Berkeley Heights,New JerseyBristol 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.

Keywords: Bristol Myers Squibb, New York , Associate Director, Nonclinical Biostatistics, Executive , Berkeley Heights, New York