Lead Biostatistician

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🕒 2 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Strong ability to apply statistics in the analysis of clinical trials • Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia • Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements • Demonstrated ability in presenting results and defending statistical findings, study design and analysis • Excellent oral and written English communication skills • Strong knowledge of current CDISC standards for ADaMs • Strong fundamentals of Project Planning and Project Management • Demonstrated ability to immediately dive into detailed and/or complex projects • Strong SAS programming skills in applying statistical procedures based on complex study designs • Perform all duties and responsibilities associated with the Study Supporting Statistician role • Oversee the work performed by multiple Study Supporting Statisticians • Review work performed by Study Supporting Statistician and provide guidance to meet the study and project requirements • Attend Clinical Study Team (CST) meetings and provide all required statistical input related to strategy and operations of the clinical study • Plan and execute statistical contributions to Study Outlines, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key- study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications • Assist in resource planning for assigned projects • Be familiar with all Company’s policies, SOPs and other controlled documents related to all study activities performed • Be familiar with statistical policy and strategy • Assist with study and systems audits conducted by Company GCA and external bodies • Stay abreast of latest developments in the field of statistics in drug development

🎯 Requirements

• Master’s degree in Statistics/Biostatistics or other subject with high statistical content with 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content with 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research • Strong skill in communicating statistical information clearly and concisely (written and oral) • Strong understanding of statistical concepts related to the design and conduct of clinical studies

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways