Previous Job
Previous
PASS study Statistician
Ref No.: 18-02996
Location: melvern, Pennsylvania
Position Type:Direct Placement
Start Date: 03/20/2018
Responsibilities:
  • Provide statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, review investigator initiated study proposals, and HEOR/Epidemiology/Pharmacovigilance.
  • Contribute/lead clinical study design and study concept, analysis planning and the development of study protocols, evaluation of sample size evaluation, statistical analysis plan (SAP), and data presentation plan for Medical Affairs and PASS studies.
  • Serve as a primary contact with vendors in implementation of studies and coordinating the work of CROs.
  • Pursue rigorous statistical analyses in support of business-critical needs.
  • Explore and implements innovative statistical methods.
  • Overseeing implementation of SAP or participating in production of reporting (TLGs)

Qualifications:
  • MS or Ph.D. in Statistics or related field with a minimum of 10 years relevant experience
  • Experience working in Medical Affairs Statistics and PASS studies including:
    • Observational study Design (case-control, cohort, registry, case-cohort, ...)
    • Bias and confounding and methodologies to control (Propensity scores, disease scores, instrumental variables), sampling strategies
    • Experience in Effectiveness Research with Longitudinal Healthcare Databases
  • Experience in the area of Pain, Respiratory, Neurology, Immunology, or Oncology research is preferred
  • Experience of working with, and coordinating the work of CROs.
  • In-depth working knowledge of statistical software such as SAS is required.
  • Demonstrated experience as an individual contributor is required while managing workflow in a cross-functional matrix organization is preferred.
  • Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials is required.
  • Excellent verbal and written communication skills, including formal presentation skills is required.
  • Ability to successfully multi-task and work independently, under minimal supervision; excellent teamwork skills are required.
  • Ability to influence, negotiate and communicate with both internal and external customers is required