Regulatory Submission Biostatistician

4 days ago

Dublin, Dublin City, Ireland Syneos Health, Inc. Full time
Why Work at Syneos Health, Inc.
We are 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. Our company culture emphasizes collaboration, innovation, and excellence, and we are committed to building a diverse, inclusive, and authentic workplace.

About the Role
This Principal Biostatistician position is an opportunity to work on high-profile projects and contribute to the development of new therapies. The ideal candidate will have extensive experience in clinical trials, a strong background in statistical design, analysis, and programming techniques, and excellent communication skills.

Main Responsibilities
* Serve as a statistical department resource, mentoring biostatisticians on job skills and overseeing 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* Supports across all statistical tasks during the lifecycle of the project, from protocol to CSR* Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures

Requirements
* Integrated analysis specific role* Prior experience with integrated analysis tasks like IASAP and TLF specification preparation, clarifications with clinical team, specification of additional derivations needed in the pool, review of draft tables, planning and coordination of additional analyses for the label* Deep knowledge of products - clinical development plan, specifically submission strategy* 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* Excellent written and verbal communication skills

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