Principal Biostatistician

Job description

Principal Biostatistician - United States (Remote) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We have an incredible opportunity for a Principal Biostatistician to join ICON’s Full-Service Biostatistics team. The Principal Biostatistician will lead and oversee small to medium sized and simple to high complex Phase I-III clinical trials. They will provide input to statistical components including protocol, mock shells, SAP text, programmed deliverables and CSR. Location: United States (Remote) What you will be doing: Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports Program using SAS and/or R for inferential statistics Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients Participate in bid defense meetings and make presentations at marketing meetings with prospective clients Mentor or provide support to junior statisticians Lead or partake in initiatives to improve internal processes or create new guidance Your profile: Master's degree OR Ph.D in Biostatistics, Statistics, or a related field 9+ years of biostatistical experience with Master’s degree OR 7+ years of biostatistical experience with Ph.D Experience leading Phase I-III studies, including client facing responsibilities, timeline management, and resource oversight Experience with Oncology, Rare Disease, Infectious Disease/Vaccine, and/or Cardio-Metabolic Disorders (preferred) Experience working in a clinical research organization (preferred) Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications) Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies Effective written and oral communication skills with demonstrated leadership ability Ability to prioritize with strong time management skills #LI-TP1 #LI-Remote Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee? Please click here to apply