Principal Biostatistician - Medical Affairs (FSP)

Thermo Fisher Scientific8 LocationsonsiteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day, enabling our customers to make the world healthier, cleaner and safer. We empower our global teams with the resources and opportunities needed to achieve their individual career goals while advancing science through innovative solutions to some of the world's most complex challenges. From protecting the environment and ensuring food safety to supporting the discovery of life-changing cancer treatments, our work makes a meaningful difference. About the Opportunity You will have the opportunity to support an innovative, science-driven global biotechnology company focused on developing transformative therapies for people living with severe autoimmune diseases. Working in a dynamic and collaborative environment, you will contribute to a growing portfolio of clinical research programmes, helping generate the scientific evidence needed to better understand treatments and improve patient outcomes. This is an exciting opportunity to apply your statistical expertise within a highly innovative therapeutic area, collaborate with leading scientific experts and play a key role in advancing research with the potential to make a meaningful difference in patients' lives. Key Responsibilities As part of the Medical Affairs Statistics team, you will provide strategic statistical expertise and oversight across clinical research programmes, with a particular focus on Phase IIIb/IV clinical trials, observational studies and patient registries supporting post-marketing commitments and requirements. You will serve as a key statistical representative within cross-functional teams, providing scientific leadership while managing multiple studies and projects simultaneously. Clinical Study Design and Statistical Leadership 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) for Medical Affairs studies. Support post-hoc analyses, investigator-initiated studies and other research activities. Ensure the scientific rigour, statistical integrity and quality of clinical research deliverables. Medical Affairs and Cross-Functional Collaboration Act as the statistical representative on cross-functional project teams, providing expert guidance on study design, methodology and data interpretation. Collaborate with Medical Affairs, HEOR, Epidemiology, Market Access and other functions to support evidence-generation strategies. Provide statistical input into product development and regulatory submission-related activities. Support publication planning and the development of scientific communications. Scientific Publications and External Engagement Serve as a primary statistical contact for external investigators, research partners and vendors. Collaborate on the preparation of scientific manuscripts, publications, abstracts and conference presentations. Engage with external Key Opinion Leaders (KOLs) to support scientific discussions and research initiatives. Communicate complex statistical findings clearly to both technical and non-technical audiences. Statistical Innovation and Research Excellence Conduct rigorous statistical analyses to support business-critical research questions and evidence-generation activities. Explore and implement innovative statistical methodologies to address complex clinical research challenges. Identify opportunities to enhance statistical approaches, analytical efficiency and the scientific value of research outputs. Contribute to the continuous improvement of statistical practices and processes.

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