Principal Biostatistician

🕒 November 25, 2025

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 69%

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Bioforum the Data Masters

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

☁️ SaaS

Biotechnology • Pharmaceuticals • SaaS

Bioforum the Data Masters is a biometric Contract Research Organization (CRO) that provides data-focused clinical development services to biotech and pharmaceutical sponsors. The company offers end-to-end clinical trial support including data management, biostatistics, statistical programming (SDTM/ADaM/TFLs), medical writing, project management, and regulatory submission support. Bioforum also develops analytics and validation tools—such as the BioGRID visualization platform with the AI assistant BRIAN, JetConvert for SDTM packages, and Validify for CDISC validation—positioning it as both a service provider and SaaS-enabled analytics vendor for clinical trial oversight and submissions. They serve startups, biotechs, and global pharmaceutical companies with FSP/rescue study models and expert-led solutions to optimize study design, data quality, and regulatory readiness.

📋 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