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.
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.
- 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
REQUIREMENTS AND SKILLS: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
- Problem Solving
- Decision Making
- English knowledge
TYPE OF CONTRACT:
Long Term contract Staff Leasing
IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).8 novembre 2022