Principal Biostatistician

2 weeks ago

Dublin, Dublin City, Ireland Syneos Health, Inc. Full time
Principal Biostatistician (Medical Affairs Required)

Updated: Yesterday
Location: Ireland-Europe - IRL-Home-Based
Job ID:25001897

*Must be located in UK, Ireland, Hungary, Greece, Poland, Spain, South Africa, Romania, Ukraine, Mexico, Argentina, Brazil, or Columbia to be considered.

Principal Biostatistician (Medical Affairs)

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.

Job responsibilities

  1. Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
  2. Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
  3. Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
  4. Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
  5. May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
  6. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
  7. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
  8. Implements company objectives, and creates alternative solutions to address business and operational challenges.
  9. As biostatistics representative on project teams, interfaces with other departmental project team representatives.
  10. Conducts and participates in verification and quality control of project deliverables.
  11. May lead complex or multiple projects (e.g. submissions, integrated analyses).
  12. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
  13. Provides statistical programming support as needed.
  14. May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
  15. Maintains well organized, complete, and up-to-date project documentation.
  16. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
  17. Performs other work-related duties as assigned.
  18. Minimal travel may be required.

Qualifications

What we're looking for

  1. Must have previous lead experience within a Medical Affairs Clinical Trial Setting.
  2. Graduate degree in biostatistics or related discipline.
  3. Extensive experience in clinical trials or an equivalent combination of education and experience.
  4. Proficiency in programming.
  5. Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.
  6. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project.
  7. Experience with regulatory submissions preferred.
  8. Excellent written and verbal communication skills.
  9. Ability to read, write, speak, and understand English.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway.

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