Principal Biostatistician – Medical Affairs

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⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide strategic statistical expertise and oversight across clinical research programmes, particularly Phase IIIb/IV clinical trials, observational studies and patient registries • Serve as a key statistical representative within cross-functional teams and provide scientific leadership across multiple studies and projects • Provide statistical expertise and oversight for clinical trials, observational studies, patient registries and other clinical research initiatives • Lead or contribute to clinical study design, statistical analysis planning and interpretation of study results • Develop and review Statistical Analysis Plans (SAPs) and Data Presentation Plans (DPSs) • Support post-hoc analyses, investigator-initiated studies and other research activities • Ensure scientific rigour, statistical integrity and quality of clinical research deliverables • Collaborate with Medical Affairs, HEOR, Epidemiology, Market Access and other functions on evidence-generation strategies • Provide statistical input into product development and regulatory submission-related activities • Support publication planning and scientific communications • Serve as primary statistical contact for external investigators, research partners and vendors • Collaborate on scientific manuscripts, publications, abstracts and conference presentations • Engage with external Key Opinion Leaders (KOLs) on scientific discussions and research initiatives • Communicate complex statistical findings to technical and non-technical audiences • Conduct rigorous statistical analyses for business-critical research questions and evidence-generation activities • Explore and implement innovative statistical methodologies • Identify opportunities to improve statistical approaches, analytical efficiency and scientific value of research outputs • Contribute to continuous improvement of statistical practices and processes

🎯 Requirements

• PhD or MSc in Statistics, Biostatistics or a related discipline • Minimum of 6 years of relevant experience for PhD holders or 8 years for MSc holders • Previous experience supporting Medical Affairs statistical activities within the pharmaceutical or biotechnology industry preferred • Experience working independently as a statistical contributor and providing scientific leadership across multiple projects • Experience working within a cross-functional, matrix-based organisation preferred • In-depth working knowledge of SAS and R • Intermediate to advanced expertise in applied biostatistical methodologies, particularly pharmaceutical and clinical research applications • Strong understanding of clinical trial design, statistical analysis, data interpretation and evidence generation • Knowledge of Good Clinical Practice (GCP) and regulatory requirements governing clinical drug development and clinical trials • Ability to apply appropriate statistical methodologies to complex scientific and clinical research questions • Excellent written and verbal communication skills • Experience presenting statistical findings to technical and non-technical audiences, including at public or scientific meetings • Strong scientific writing skills and experience contributing to peer-reviewed publications and journal articles preferred • Ability to build effective relationships and collaborate with internal stakeholders, external investigators and scientific experts • Strong influencing, negotiation and stakeholder-management skills • Ability to manage multiple priorities and projects effectively • Highly organised, proactive and capable of working independently with minimal supervision • Strong analytical thinking, problem-solving skills and attention to detail • Excellent teamwork and collaboration skills • Commitment to scientific excellence, innovation and continuous improvement

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