Chiesi Farmaceutici è alla ricerca di uno statistician con almeno 5 anni di esperienza
Luogo: Parma (Italia)
Education: Master degree or PhD in Statistics.
Job Responsibilities:
• To contribute to the definition of Clinical Development Plans, regulatory strategy and submissions
• Statistical input to clinical studies (study design, sample size calculations and statistical methodology), ensuring methods are applied consistently within a program and in line with regulatory guidelines.
• To support clinical study setup (input on CRF design, database design, specifications for randomization, IRT, ePRO and other external data).
• To interact with CROs and other external vendors to oversee statistical activities, ensuring high level of quality and timely delivery
• To write/review/develop/approve all study related statistical documents: Data Review Plan, Statistical Analysis Plan, Data Quality Report
• To lead data review activities before database lock
• To review Clinical Study Reports
• To drive data interpretation, to plan and conduct statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses and other analyses requested by regulatory agencies
• To provide specifications to SAS programmers
• To collaborate in writing regulatory documents, eCTD submission modules; to represent Chiesi as statistician attending meeting with Regulatory Authorities.
• To write/review abstracts, posters and presentations.
Technical capabilities:
• Strong experience of clinical development and regulatory requirements
• In depth knowledge of statistical methods that apply to clinical trials: from first in human and PK studies, to phase II dose-finding and pivotal studies.
• Experience of regulatory interactions and submissions
• Knowledge of international standards (CDISC SDTM and ADaM) and FDA requirements
• Good SAS programming
Skills:
• Excellent communication skills and ability to establish good collaboration both internally and externally
• Strong commitment to quality
• Problem solving attitude
• Languages: Proficiency in both written and spoken English is a must.
Se interessati contattare:
Lucia Santambrogio: l.santambrogio@chiesi.com