Principal Biostatistician

Principal Biostatistician (Medical Affairs - CAN & Europe)

Syneos Health is a leading fully 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 Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Working at Syneos Health means you join a global team of 29,000 employees across 110 countries where work matters everywhere.

Why Syneos Health: we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture and to taking care of our people. We value diversity of thoughts, backgrounds, cultures and perspectives, so everyone can belong.

• Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to ensure data are adequately captured to answer study objectives and support planned statistical analyses.
• Be accountable for all statistical deliverables related to the study: statistical sections in protocol (including sample size calculation, randomization specifications, and statistical methodology), Statistical Analysis Plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables).
• Effectively utilize external groups (e.g., CROs or data monitoring committees).
• Work with the programming team to provide definitions, documentation and review of derived variables, and the quality control plan.
• Perform and/or coordinate with study programmers the production of statistical analyses; review and examine statistical data distributions/properties.
• Oversee execution of statistical analyses according to the SAP; prepare statistical methods and provide statistical insight into interpretation and discussion of results sections for the CSR and/or publications to ensure statistical integrity in accordance with internal standards and regulatory guidelines.
• Propose, prepare and perform exploratory data analyses and ad-hoc analyses as relevant for study objectives.
• Contribute to define and review deliverables related to Transparency and Disclosure.
• Plan and track study/project activities and timelines.
• Ensure productive collaborations with other functions in the study team, promoting teamwork, quality, operational efficiency and innovation.

• PhD or MS in statistics or related discipline with at least 5 years of pharmaceutical experience.
• Good knowledge of pharmaceutical clinical development, with late phase and/or post-marketing activities.
• Broad knowledge and understanding of advanced statistical concepts and techniques.
• Ability to work in a departmental computing environment; proficient in advanced statistical analyses using SAS and possibly other languages (e.g., R).
• Demonstrated strong interpersonal, communication, and writing skills.
• Experience in clinical development including interaction with external stakeholders.

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion with no prior notice. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes equivalent qualifications. Nothing herein should be construed to create an employment contract. The language herein is intended to comply with obligations of the country of operation, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including provision of reasonable accommodations when appropriate to assist employees or applicants.

Summary: Only open to Canada and Europe. Previous experience leading medical affairs clinical studies is required.