Principal Biostatistician

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November 25

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BioForum

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Biotechnology • Non-profit • B2B

BioForum is the Polish Association of Biotechnology Companies (Związek Firm Biotechnologicznych BioForum). It facilitates exchange of information, research results and best practices among member companies, represents their collective voice to regulators and policymakers at national and European levels, and advocates for policy supporting biotechnology innovation. BioForum organizes conferences and events (CEBioForum, GreenBioForum), provides specialized training, webinars and networking platforms (CEBioForum platform, #POLISHBIOTECH database), and collaborates with government agencies, industry clusters and international bodies to promote the growth and internationalization of Poland’s biotech sector.

1 - 10 employees

Founded 2021

🧬 Biotechnology

🤝 Non-profit

🤝 B2B

📋 Description

• Works alongside the Director: Biostatistics to provide biostatistical support and services related to clinical trials. • Act as Statistical Lead on clinical trials. • Ownership of the statistical aspects and requirements on clinical trials done by Bioforum. • Provide guidance on study designs and statistical methodology as appropriate. • Interact with the customer and provide guidance / input on the statistical requirements and queries in the planning and during the conduct of the trial. • Statistical review and preparation of documentation, including the statistics section of the study protocol, Statistical Analysis Plan, and statistical sections / results interpretation of Clinical Study Reports (CSRs). • Provide training/mentorship to junior statisticians. • Review Table, Listing and Figure (TLF) shells associated with the study SAP. • Review ADaM and/or derived dataset specifications as required. • Development of SAS programs for study TLFs focussing on efficacy and/or advanced statistical methodology. • Review statistical output produced by the statistical programming team. • Contribute to department wide initiatives to improve quality and efficiency.

🎯 Requirements

• Minimum 8 years’ experience as a biostatistician working on clinical trials. • Knowledge of advanced statistical methodology used in the analysis of clinical trial data • In-depth knowledge of industry guidelines (GCP, ICH E9, regulatory guidelines) • Study / Project lead / Customer interaction experience • Attention to detail. • Excellent communication skills. • An Honours degree (a Masters degree / Ph.D will be an advantage) in a statistics related field. • Experience interacting with a regulatory agency will be an advantage