Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)

Overview

Principal 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.

Responsibilities

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 designs 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 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 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 CRFs, database design, and other study documentation to ensure data is captured as required to support analysis

Implements company objectives and creates alternative solutions to address business and operational challenges

Represents biostatistics on project teams and interfaces with other departmental representatives

Prepares in advance for internal meetings, contributes ideas, and respects opinions of others

Conducts verification and quality control of project deliverables to ensure alignment with SAP and specifications

May lead complex projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions to support statistical results

Manages scheduling and time constraints across multiple projects, communicates with management about timelines and prioritizes tasks as needed

Monitors progress against milestones and identifies out-of-scope tasks for escalation

Provides statistical programming support as needed

May participate in DSMB / DMC activities, including charter development and serving as an independent non-voting biostatistician; may serve as a voting statistician when required

Provides input and adheres to SOPs, WIs, and regulatory guidelines (e.g., ICH)

Maintains organized project documentation and verification / quality control programs for inspection readiness

Supports business development activities by contributing to proposals and sponsor meetings

Performs other duties as assigned; minimal travel may be required

Qualifications

Strong knowledge on Biomarker evaluation, esp. In Oncology, ctDNA data, relevant parameters and underlying biology

Graduate degree in biostatistics or related discipline

Extensive experience in clinical trials or equivalent education / experience, demonstrated by the ability to lead multiple projects

Proficiency in programming

Ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research and to communicate statistical concepts

Experience across all statistical tasks required to support clinical trials from protocol to CSR

Experience with regulatory submissions preferred

Excellent written and verbal communication skills

English language proficiency (read, write, speak, understand)

Get to know Syneos Health

Syneos 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 Information

Tasks, 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.

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