Principal Statistician

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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 teams on statistical questions • Conduct statistical analyses for clinical trials, including interim, final, DSMB/DMC, and PK analyses • Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM, and other project-specific documents • Review statistical deliverables, including tables, figures, listings, and analysis datasets • Conduct departmental induction courses 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 audit follow-up • Provide input to standard operating procedures and Quality Systems Documents pertinent to Biostatistics • Liaise with Data Management on statistical questions related to data issues • Participate in bid defense and kick-off meetings • Lead teams of SAS programmers and/or statisticians at the project level • Serve as biostatistics project lead when required

🎯 Requirements

• MSc in Statistics or equivalent • Expert knowledge and understanding of statistical principles, concepts, methods, and standards used in clinical research • Expert knowledge and understanding of SAS programming • Expert knowledge and understanding of the 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, including FDA, EMA, and ICH • Ability to apply advanced statistical techniques in clinical research studies • Ability 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