Senior 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

• Lead all biostatistics activities related to clinical trials as responsible project statistician • Communicate with project teams, clients and vendors on statistical questions • Develop and review statistical sections of protocols, including sample size calculations • Develop statistical analysis plans • Develop and document analysis database structures (i.e. SAS analysis data set structures) • Develop SAS program requirements and specifications • SAS programming and program validation • Review and QC of statistical deliverables (tables, listings, figures, etc.) • Perform statistical analysis and report results • Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products • Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics • Participate in bid defense meetings and kick-off meetings • Train statisticians and SAS programmers • Prepare and deliver presentations at investigators' meetings • Address audits findings/recommendations, and follow-up on and resolution of audit findings

🎯 Requirements

• MSc in Statistics or equivalent • Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research • Ability to apply a range of 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 • Expert knowledge and understanding of the SAS programming • Expert knowledge and understanding of CDISC ADaM standard • Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH) • Ability to work in English

🏖️ Benefits

• Employees can work remotely