Principal Biostatistician

OverviewPrincipal Biostatistician (Biomarker Analyst - EMEA and US BASED) role at Syneos Health .Description Principal Biostatistician (Biomarker Analyst -EMEA and US BASED) at Syneos Health. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success by translating clinical, medical affairs and commercial insights into outcomes.Our Clinical Development model centers the customer and the patient. We strive to simplify and streamline our work to better support our customers and our teams. You will collaborate with problem solvers in an agile environment to help our customers achieve their goals and accelerate the delivery of therapies.ResponsibilitiesCollaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics and devices) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statisticianDevelops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projectsFacilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projectsConducts and designs advanced data analysis for genomics and biomarker statistics, including statistical programming, and designs complex analysis algorithmsAssumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the resultsWorks independently at routine and complex statistical questions and tasksDevelops and implements standard processes for the analysis of routine biomarker assessmentsServes as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associatesDirects the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality workProvides support across all statistical tasks during the lifecycle of the project, from protocol to CSRPrepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of mock-up displays for tables, listings, and figuresMay be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study reportCreates or reviews programming specifications for analysis datasets, tables, listings, and figuresReviews SAS annotated CRFs, database design, and other study documentation to ensure data is captured as required to support analysisImplements company objectives and creates alternative solutions to address business and operational challengesRepresents biostatistics on project teams and interfaces with other departmental representativesPrepares in advance for internal meetings, contributes ideas, and respects opinions of othersConducts verification and quality control of project deliverables to ensure alignment with SAP and specificationsMay lead complex projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions to support statistical resultsManages scheduling and time constraints across multiple projects, communicates with management about timelines and prioritizes tasks as neededMonitors progress against milestones and identifies out-of-scope tasks for escalationProvides statistical programming support as neededMay participate in DSMB/DMC activities, including charter development and serving as an independent non-voting biostatistician; may serve as a voting statistician when requiredProvides input and adheres to SOPs, WIs, and regulatory guidelines (e.g., ICH)Maintains organized project documentation and verification/quality control programs for inspection readinessSupports business development activities by contributing to proposals and sponsor meetingsPerforms other duties as assigned; minimal travel may be requiredQualificationsStrong knowledge on Biomarker evaluation, esp. In Oncology, ctDNA data, relevant parameters and underlying biologyGraduate degree in biostatistics or related disciplineExtensive experience in clinical trials or equivalent education/experience, demonstrated by the ability to lead multiple projectsProficiency in programmingAbility to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research and to communicate statistical conceptsExperience across all statistical tasks required to support clinical trials from protocol to CSRExperience with regulatory submissions preferredExcellent written and verbal communication skillsEnglish language proficiency (read, write, speak, understand)Get to know Syneos HealthSyneos Health has worked with numerous FDA-approved drugs and EMA-authorized products, with extensive experience across many studies and sites. We value initiative, collaboration, and adaptability in a dynamic environment.Additional InformationTasks, duties, and responsibilities are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and/or education may be considered. The company will determine what constitutes equivalent qualifications. This description is not an employment contract. The company complies with applicable laws and regulations, including reasonable accommodations under applicable laws.#J-18808-Ljbffr