Dettagli

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Senior Statistician who can join an exciting working environment in a dynamic atmosphere.

Job Description:

Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs; provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables; provide/oversee statistics support to clinical trials, ensuring that data are collected, analyzed and evaluated with statistical rigor.

Ruolo

Responsibilities:

  • Provides statistical input in support of Drug Development  Programs
  • Provides statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results
  • Interacts with CROs and supervise statistical activities
  • Reviews/Develops the Statistical Analysis Plan, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports
  • Plans and conducts statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies
  • Conducts all the statistical activities for the Blind Review Meeting
  • Reviews the Clinical Study Report
  • Collaborates in writing regulatory document, reviews sections of regulatory submissions, attends meetings with regulatory agencies to support drug registration
  • Manages the statistical deliverables required by eCTD submission
  • Reviews abstracts, posters, presentations for publication
  • Contributes to definition of SOPs
Profilo
  • University Degree Statistics
  • A significant experience in clinical statistics
  • Capability to provide statistical leadership to cross-functional teams at the protocol level
  • Strong statistical skills with application to clinical trials
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  • Demonstrated professional experience in pharmaceutical industry work, e.g., clinical trial design and analysis, regulatory submissions, product defense, publications, and marketing support.
  • Verbal Communication
  • Teamworking
  • Problem Solving
  • Decision Making
  • English knowledge
Offerta

Long Term contract – Staff Leasing

Per candidarti invia i tuoi dati a TalentAcquisitionCSMSItaly@iqvia.com