Principal Biostatistician, RWE – PASS Experience

🔥 3 minutes ago

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Syneos Health

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates. • Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. • Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. • Reviews SAS annotated case report forms (CRFs), SAS 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. • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. • Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.

🎯 Requirements

• 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 with regulatory submissions preferred. • Excellent written and verbal communication skills. • Ability to read, write, speak, and understand English.

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time.

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