Principal Statistician

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Contribute to statistical activities related to global clinical trials • Work closely with international teams of statisticians, programmers and data managers • Act as a communication line for project teams, clients, vendors and internal team on statistical questions • Conduct statistical analysis for clinical trials • Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents • Review statistical deliverables such as tables, figures, listings and analysis datasets • Conduct departmental induction course and project-specific training for statisticians and SAS programmers • Prepare for and attend internal and external study audits pertinent to Statistics • Participate in preparation of internal/external audits follow up • Provide input to standard operating procedures and other Quality Systems Documents pertinent to activities of Biostatistics department • Liaise with DM on statistical questions related to data issues • Participate in bid defense and in kick-off meetings • Lead teams of SAS programmers and/or statisticians on the project level

🎯 Requirements

• MSc in Statistics or equivalent • Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research • Expert knowledge and understanding of the SAS programming • Expert knowledge and understanding of CDISC ADaM standard • Expert knowledge and understanding of adaptive designs • Expert knowledge and understanding of sample size calculation • Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) • Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information • Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies • Strong presentation and communication skills

🏖️ Benefits

• Employees can work remotely