Sr Biostatistician (Medical Affairs - Ophthalmology)
Updated: February 17, 2025
Location: Ireland-Europe - IRL-Home-Based
Job ID:25001659
Senior Biostatistician (Medical Affairs Ophthalmology)
*Previous experience within Ophthalmology is required
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.
Job Responsibilities
1. Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
2. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
3. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
4. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.
5. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
6. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
7. Implements company objectives, and creates alternative solutions to address business and operational challenges.
8. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.
9. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
10. Provides statistical programming support as needed.
11. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities.
12. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed.
13. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
14. Maintains well organized, complete, and up-to-date project documentation.
15. Coaches and mentors other Biostatistics staff.
16. Performs other work-related duties as assigned.
17. Minimal travel may be required.
Qualifications
What we’re looking for
• Graduate degree in biostatistics or related discipline.
• Moderate experience in clinical trials or an equivalent combination of education and experience.
• Proficiency in programming.
• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered.
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.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any legally protected status.
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