Associate Director, Real World Evidence Epidemiologist

Employer
Celgene
Location
Summit, New Jersey, United States
Posted
Jun 16, 2019
Ref
1901416
Discipline
Science/R&D, Pathology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Req #: 1901416
Location: Summit, New Jersey, United States
Job Category: Medical
Work Location: 86 Morris Avenue 07901
Organization: Registries
Employee Status: Full-time
Job Type: Regular
Other Locations: United States-California-San Francisco

The Real-World Evidence (RWE) Epidemiologist is a member of the US Medical Affairs (USMA) Registries and Real-World Data Collaborations team and oversees and/or conducts high-quality statistical analyses of RWE data to answer exploratory questions and ODQs to support Celgene Medical Teams, publication plans and/or cross-functional internal and external RWE collaboration projects in a timely manner and in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.

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

  • Provides expert guidance, direction, and execution of analyses to support timely, targeted and accurate reporting and outcomes from assigned real-world evidence projects.
  • Provides technical solutions to a wider range of problems with higher level of complexity, independently determines and develops approach to solutions, and recommends technical and process solutions that can be used or developed to increase efficiency of project work.
  • Provides analytical and methodological expertise on RWE studies in Medical Affairs.
  • Can summarize and communicate observational data and analytical results effectively and clearly, written and verbally, to internal and external customers and stakeholders.
  • Understands the necessity for extensive collaboration and multi-functional input on RWE analyses conduct and interpretation.
  • Has experience working with CROs, particularly real-world data providers and analytics service providers, and can evaluate vendor products and software for feasibility and applicability to in-house analytic needs.
  • Provides programming input to CRF or chart abstraction forms, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells for Celgene RWE studies in Medical Affairs.
  • Writes SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
  • Performs ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
  • Provides input to the design of the RWE database, if applicable, for proper data capture and to ensure data quality.
  • Able to convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
  • Contributes to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
  • Conducts routine QC checks of data quality, completeness and programming outputs as determined by RWE Statistician and Study Team and maintain reliable, complete records of QC.
  • Routinely interface with cross-functional team members.
  • Working closely with internal study team, oversee the services provided by CROs.
  • Can summarize and communicate observational data and analytical results effectively and clearly, written and verbally, to internal and external customers and stakeholders.
    Education and Experience Guidelines:

    Minimum Basic Qualifications :

  • PhD, MSc. or MPH in Epidemiology, Pharmacoepidemiology preferred, or related field with a substantial statistical component
  • A minimum of 5 years' experience in statistical programming of clinical observational data, SAS programming preferred
  • At least 5 years' experience analyzing observational data that includes patient registry data or electronic health records data
  • A minimum of 5 years working in the pharmaceutical industry, areas of oncology or hematology preferred
Relationship Management
  • Development/maintenance of collaborative relationships with:
    • USMA Registry/RWD Collaborations Team and specific study teams, particularly with the RWE data analyst, study biostatistician and/or study programmer(s) (if applicable), and RWE study or safety epidemiologist
    • internal partners/stakeholders including Medical Affairs, Market Access, IPS, Clinical Research, CR&D Operations, Affiliates and Project Management
    • external partners including Scientific Steering Committee, Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers, if applicable.

Continuous Improvement

  • Collaborate with colleagues within Medical Affairs and from other Departments to maximize efficiencies, share and apply best practices.
  • Stays current on advanced analytics training, including mining and linking large observational databases as well as knowledge of integrated database systems and data warehouses.
  • Flag potential process improvement opportunities and support execution.


About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.