Bristol Myers Squibb Company

PK Scientist, Clinical Pharmacology Analysis and Reporting

Location
Princeton, NJ, United States
Posted
Sep 16, 2020
Ref
R1526678
Required Education
Bachelors Degree
Position Type
Full time

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.

Clinical Pharmacology & Pharmacometrics is a key partner in the quantitative integration and interpretation of multi-source data to better characterize and differentiate compounds, thus adding value and enhancing decision quality throughout the R&D continuum. Clinical Pharmacology Analysis and Reporting is responsible for ensuring that study-level PK analysis and reporting is standardized across protocols and programs.

  • In this role, the individual will review the pharmacokinetic section of a protocol, case report form and spec document and setup the pharmacokinetic database.
  • This individual will also review the pharmacokinetic concentration data, perform pharmacokinetic data analysis, author some components of the clinical study report and liaise with the Clinical Pharmacology Leads to understand the needs of the study and keep them informed of the status of pharmacokinetic analysis.

 


• In this role, the individual will have the responsibility to review the pharmacokinetic section of a clinical protocol, ensure the

pharmacokinetic components of the clinical case report form and the spec document match the protocol requirements and then create the

pharmacokinetic data base according the specifications dictated in the protocol and the expectations of departmental guidelines.

• This individual would also be responsible to review the pharmacokinetic

concentration data for potential errors and coordinate the cleaning and

tracking of PK metadata according to provided specifications.

• This individual would then transfer the cleaned data to the analysis program and conduct the expected non-compartmental pharmacokinetic

analysis according to protocol and departmental specifications.

• From the analysis program, this individual would then create tables, listings, and figures according to the statistical analysis plan for the study

and, when final, upload them to the proper document repository for access by the medical writer.

• This individual may also be responsible for reviewing pharmacokinetic

components of the statistical analysis plan and authoring some components of the clinical study report.

• This individual will liaise with the Clinical Pharmacology Leads and

protocol Study Directors in the Therapeutic Areas to understand the

particular needs of the study and to keep them informed to the status of pharmacokinetic analysis.

• This individual will need to work with external partners for non-

compartmental analyses that are performed by our external partners. The individual will provide the relevant reference documents, analysis expectations and timelines to the external partner and also QC their work.

Requirements

Bachelors in pharmacology/pharmacokinetics/pharmaceutical/biological sciences or related field or Masters in pharmacology/pharmacokinetics/pharmaceutical/biological sciences or related field

• 1-2 years of pharmaceutical industry experience with Bachelor's degree or

• 0-2 years of pharmaceutical industry experience with a Master's degree

• Experience with PK analysis using Phoenix WinNonlin

• Experience working in a highly matrixed organization

• Strong communication and multi-tasking skills

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.