Principal Biostatistician; Biomarker Analyst -EMEA

Overview

Principal Biostatistician (Biomarker Analyst
-EMEA and US BASED)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. WORK HERE MATTERS EVERYWHERE.

• Collaborates 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 statistician.
• Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects.
• Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and 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 on routine and complex statistical questions and tasks.
• Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments. Possible additional tasks:
• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions or trains new hires and enhances the skills of existing personnel.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians in the department.
• 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. Collaborates with sponsor, if required.
• 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 to support a high quality database and the planned analysis.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• As biostatistics representative on project teams, interfaces with other departmental project team representatives.
• Preparing in advance for internal meetings, contributing ideas, and demonstrating 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 respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the…