Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)

Syneos Health-posted 2 months ago
Full-time • Senior
Morrisville, NC
5,001-10,000 employees
Professional, Scientific, and Technical Services
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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. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

  • Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects of clinical studies or biomarker studies in the role of the biomarker 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.
  • Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design 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 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.
  • 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.
  • 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.
  • Conducts and participates in verification and quality control of project deliverables.
  • May lead complex or multiple projects and attend regulatory agency meetings or respond to questions.
  • Manages scheduling and time constraints across multiple projects.
  • Monitors progress on study activities against agreed upon milestones.
  • Provides statistical programming support as needed.
  • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
  • Maintains well organized, complete, and up-to-date project documentation.
  • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
  • Strong knowledge on 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.
  • Proficiency in programming.
  • Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.
  • Experience across all statistical tasks required to support clinical trials during the lifecycle of the project.
  • Experience with regulatory submissions preferred.
  • Excellent written and verbal communication skills.
  • Ability to read, write, speak, and understand English.
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