Job Summary
We are seeking an experienced Biostatistician to lead our statistical team and contribute to the development of clinical trials. The successful candidate will have a strong background in biostatistics, excellent communication skills, and the ability to work effectively in a team environment.
Key Responsibilities:
* Serve as a statistical resource and mentor for biostatisticians on job skills and training plans.
* Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
* Provide independent review of project work produced by other biostatisticians in the department.
* Support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
* Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
* Create or review programming specifications for analysis datasets, tables, listings, and figures.
* Review 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.
* Implement company objectives and create alternative solutions to address business and operational challenges.
* Interface with other departmental project team representatives.
* Conduct and participate 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 and attend regulatory agency meetings or respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
* Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, discuss time estimates for completion of study-related activities with biostatistics management, adapt to timeline or priority changes by reorganizing daily workload, and proactively communicate to biostatistics management any difficulties with meeting these timelines.
* Monitor progress on study activities against agreed-upon milestones and ensure the study timelines for project deliverables are met. Identify out-of-scope tasks and escalate to management.
* Provide statistical programming support as needed.
* May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.
* Provide input and reviews and subsequently follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
* Maintain well-organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
* Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
* Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
* Perform other work-related duties as assigned.
Qualifications:
* Experience with late-phase studies working within HEOR and/or HTA is required.
* Graduate degree in biostatistics or related discipline.
* Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.
* Proficiency in programming.
* Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
* Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
* Experience with regulatory submissions preferred.
* Excellent written and verbal communication skills.
* Ability to read, write, speak, and understand English.
About Syneos Health
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. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Contact Information
No phone numbers or email addresses available at this time.