Statistical Department Lead

5 days ago

Dublin, Dublin City, Ireland Syneos Health, Inc. Full time
Job Overview

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. As Principal Biostatistician, you will be an integral part of our team responsible for the statistical aspects of clinical trials.

The ideal candidate will have extensive experience in clinical trials, including knowledge of regulatory submissions, statistical design, analysis, relevant guidelines, and programming techniques utilized in clinical research. The ability to apply this knowledge effectively and communicate statistical concepts clearly is crucial for success in this role.

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

- 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.
- Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
- May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
- 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 and all data is captured as required to support a high-quality database and the planned analysis.
- Implements company objectives, and creates alternative solutions to address business and operational challenges.
- Interfaces with other departmental project team representatives.
- Conducts and participates 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.
- 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.
- Monitors progress on study activities against agreed-upon milestones and ensures the study timelines for project deliverables are met. Identifies out-of-scope tasks and escalates to management.
- Provides 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.
- 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.

About Us

Syneos Health is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients.

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