CROMSOURCE: Principal Statistician with 8+ years of experience in life science/pharmaceutical/CRO
Luogo: Verona (Italia)
Education: Advanced Degree in sciences, with substantial statistics component
Main Job Tasks and Responsibilities:
- Leads the statistical analysis of a clinical study in compliance with the analysis plan and protocol
- Provides high quality statistical support direct to our clients whilst managing projects
- Provides statistical and methodological input for sample size calculation and protocol development
- Develops a detailed statistical analysis plan and related mock shells
- Performs quality control and senior review of the tables, listings, figures, datasets, inferential analysis and statistical text
- Leads Data Review Meetings
- Writes statistical reports and/or sections for the integrated study report, reviews the draft study report, and ensures that all data presented is correct
- Responsible for project scope, efficiencies, milestones and budgets and completing work according to CROMSOURCE SOPs
- Expert person, central reviewer of ADaM datasets, deliverables and processes, keeping abreast with all regulatory developments within CDISC
- Contribute to the development, implementation and maintenance of the quality system and suggests process improvements
- Assists in providing input into RFPs and bid defense meetings
Education and Experience
- Advanced Degree in sciences, with substantial statistics component
- At least eight years of experience as a statistician in life science/pharmaceutical/CRO environment
- Proven organizational and problem solving/decision making skills
- Expert knowledge of the applicable regulatory guidance
- Proficient in SAS software
- Proficient in Microsoft Office (e.g. Word, Excel, Outlook)
- Fluent in English and local language(s)
- Good communication skills
- Advantageous, project management and leadership skills
If you are interested in this opportunity then please send your CV in English to email@example.com or apply directly at our web site https://www.cromsource.com/careers-test/job-vacancies/job-information/?job-id=HQ00001832
Chiesi Farmaceutici è alla ricerca di uno statistician con almeno 5 anni di esperienza
Luogo: Parma (Italia)
Education: Master degree or PhD in Statistics.
• 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.
• 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
• 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: firstname.lastname@example.org