Syneos Health® is a premier fully-integrated life sciences services organization designed to accelerate customer success. We partner with innovators at every stage of drug development and commercialization, guiding them through complexities and driving progress.

Our Clinical Solutions team operates with a drug development mindset, leveraging extensive experience and expertise to understand customer needs and shape effective solutions.

In this role, you will lead the development and execution of clinical development plans, including defining the Go/No Go framework. You will utilize simulations and statistical strategies to inform trial design decisions, mentor biostatisticians, and oversee training plans for associates. Your responsibilities will include directing biostatistics personnel on projects to ensure timely, high-quality work, and providing independent reviews of project outputs.

You will support statistical tasks throughout the project lifecycle, from protocol to Clinical Study Report (CSR), and prepare or oversee the preparation of Statistical Analysis Plans (SAPs). Collaboration with sponsors may be required, and you may serve as the Lead Biostatistician for statistical aspects of protocols, randomization schedules, and clinical study reports.

Your role will involve creating or reviewing programming specifications, conducting quality control of project deliverables, and leading complex projects while managing multiple timelines. You will monitor study activities against milestones, identify out-of-scope tasks, and provide statistical programming support as needed.

Additionally, you may participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, ensuring compliance with relevant SOPs and regulatory guidelines. You will maintain organized project documentation and support business development activities by contributing to proposals and attending sponsor meetings.

Qualifications include a Master’s degree in biostatistics or a related field, extensive clinical trial experience, proficiency in R programming, and excellent communication skills in English. Experience with regulatory submissions is preferred.

Join us at Syneos Health, where we are committed to developing our people and fostering an inclusive culture. Discover how you can shape the future of healthcare with us.