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.
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 database 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.
You 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, you 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.
You may also be responsible for reviewing pharmacokinetic components of the statistical analysis plan and authoring some components of the clinical study report. Act as a liaison with the Clinical Pharmacology Leads 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. Provide the relevant reference documents, develop specifications, address data issues, and communicate analysis expectations and timelines to the external partner and also QC their work.
Requirements for the position include:
- Bachelors in pharmacology/pharmacokinetics/pharmaceutical/biological sciences or related field
- 1-2 years of pharmaceutical industry experience or Masters in pharmacology/pharmacokinetics/pharmaceutical/biological sciences or related field
- 0-2 years of pharmaceutical industry experience
- Experience with PK analysis using Phoenix WinNonlin is a plus
- Experience working in a highly matrixed organization is desirable
- Strong communication and multi-tasking skills are required
- It is expected that the individual be highly self-motivated, pays attention to details and likes to contribute toward problem solving
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.