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