# Principal Biostatistician (Biomarker Analyst -EMEA and US BASED) **Company**: Syneos Health **Experience**: senior **Job type**: full-time **Category**: Data Science **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GBR-Remote/Principal-Biostatistician--Biomarker-Analyst-_25003420-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_808ba375-1d0 ## Description Syneos Health is seeking a Principal Biostatistician (Biomarker Analyst - EMEA and US BASED) to join their team. The successful candidate will collaborate with representatives from other functions to plan, execute, and analyze biomarker aspects of clinical studies. Responsibilities: - Develops the Biomarker Evaluation Plan for the study, ensuring overall consistency within and between projects - Conducts and designs advanced data analysis for genomics and biomarker statistics, including statistical programming and design of complex analysis algorithms - Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results - Works independently at routine and complex statistical questions and tasks - Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments - Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates - Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work - Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR - Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures - May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report - Creates or reviews programming specifications for analysis datasets, tables, listings, and figures - Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required - Implements company objectives and creates alternative solutions to address business and operational challenges - Interfaces with other departmental project team representatives - Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others - Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications - May lead complex or multiple projects (e.g., submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed - Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study-related activities with biostatistics management, adapts to timeline or priority changes, and proactively communicates to biostatistics management any difficulties with meeting these timelines - Monitors progress on study activities against agreed-upon milestones and ensures the study timelines for project deliverables are met - Provides statistical programming support as needed - May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician - Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH) - Maintains well-organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness - Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business - Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings - Performs other work-related duties as assigned Qualifications: - Strong knowledge of biomarker evaluation, especially in Oncology, ctDNA data, relevant parameters, and underlying biology - Graduate degree in biostatistics or related discipline - Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies - Proficiency in programming - Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts - Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR - Experience with regulatory submissions preferred - Excellent written and verbal communication skills - Ability to read, write, speak, and understand English ## Skills ### Required - biostatistics - clinical trials - statistical programming - genomics - biomarker evaluation - Oncology - ctDNA data analysis ### Nice to have - regulatory submissions - Data Safety Monitoring Board (DSMB) - Data Monitoring Committee (DMC) --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GBR-Remote/Principal-Biostatistician--Biomarker-Analyst-_25003420-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)