Clinical Trials Operations Manager
4 days ago
Are you passionate about making a meaningful impact in the lives of patients? Do you want to work for a company that values diversity, inclusion, and authenticity? If so, then join us as a Principal Biostatistician at Syneos Health.
We are seeking a highly skilled and motivated individual to lead and manage cross-functional teams to deliver high-quality statistical results on time. As a Principal Biostatistician, you will be responsible for developing and implementing statistical strategies to ensure the successful execution of clinical trials. You will also mentor biostatisticians on job skills, develop training plans or materials, conduct training sessions, and enhance the skills of existing personnel.
About the Role
This position involves directing the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work. You will provide independent review of project work produced by other biostatisticians, prepare or oversee the preparation of Statistical Analysis Plans (SAPs), and collaborate with sponsors as required. Additionally, you may be responsible for leading complex or multiple projects, attending regulatory agency meetings, and responding to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
Key Responsibilities
- Develops and implements statistical strategies to ensure the successful execution of clinical trials.
- Leads and manages cross-functional teams to deliver high-quality statistical results on time.
- Prepares and oversees the preparation of Statistical Analysis Plans (SAPs).
- Collaborates with sponsors to ensure their needs are met and provides independent review of project work produced by other biostatisticians.
- Mentors biostatisticians on job skills, develops training plans or materials, conducts training sessions, and enhances the skills of existing personnel.
- May lead complex or multiple projects, attends regulatory agency meetings, and responds to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
- Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study-related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
- Ensures the study timelines for project deliverables are met and identifies out-of-scope tasks to escalate to management.
- Participates 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.
- Maintains well-organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
- Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
- Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
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