Principal Biostatistician - Medical Affairs (FSP)

Job description

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 OpportunityYou 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 ResponsibilitiesAs 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 LeadershipProvide 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 CollaborationAct 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 EngagementServe 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 ExcellenceConduct 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. Qualifications and ExperienceEducation and Professional ExperiencePhD or MSc in Statistics, Biostatistics or a related discipline, with a 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 is preferred. Demonstrated experience working independently as a statistical contributor, with the ability to provide scientific leadership across multiple projects. Experience working within a cross-functional, matrix-based organisation is preferred. Technical and Statistical ExpertiseIn-depth working knowledge of statistical programming software, particularly SAS and R. Intermediate to advanced expertise in applied biostatistical methodologies, with a strong emphasis on 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 the conduct of clinical trials. Ability to apply appropriate statistical methodologies to complex scientific and clinical research questions. Communication and CollaborationExcellent written and verbal communication skills, including the ability to deliver clear and effective scientific presentations. Demonstrated experience presenting statistical findings to both technical and non-technical audiences, including at public or scientific meetings. Strong scientific writing skills, with 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. Personal AttributesAbility to manage multiple priorities and projects effectively in a fast-paced environment. 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. Why Join Us?At Thermo Fisher Scientific, you will have the opportunity to combine your statistical expertise with meaningful, patient-focused scientific research. You will work alongside talented professionals, contribute to innovative clinical research programmes and help generate evidence that informs treatment decisions and advances patient care. Join us in making a meaningful impact through science and helping our customers make the world healthier, cleaner and safer.