Principal Biostatistician

Updated: YesterdayLocation: CAN-RemoteJob ID:25102671OverviewSyneos 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 centers the customer and patient, while we simplify and streamline our work. Whether you join in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with problem solvers to accelerate the delivery of therapies and improve lives.WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe develop our people through career development and progression; supportive line management; training; peer recognition and total rewards.We embrace a Total Self culture – authentic, global, and supportive of our people.We foster diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging.Job ResponsibilitiesPrevious lead experience within Medical Affairs is required.Must be in Europe or North AmericaPHD RequiredServes as a statistical department resource, mentors biostatisticians, and develops training plans or materials for Biostatistics associates. Conducts training sessions and develops staff skills.Prepares Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures; collaborates with sponsor as required.Responsible for the statistical aspects of the protocol, generation of randomization schedules, and input to the clinical study report.Reviews SAS annotated CRFs, SAS database design, and other study documentation to ensure data capture supports the protocol criteria and planned analysis.Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.Directs activities of biostatistics personnel to ensure timely, high-quality work; provides independent review of project work.Implements company objectives and develops solutions to address business and operational challenges.Serves as biostatistics representative on project teams and prepares for internal meetings, sharing ideas respectfully.Performs verification and quality control of project deliverables to ensure alignment with SAP and specifications.Manages scheduling across multiple projects, sets goals, and communicates timelines; identifies out-of-scope tasks and escalates as needed.Provides statistical programming support as needed.May participate in DSMB/DMC activities; may serve as voting/non-voting statistician as applicable.Leads projects involving integrated analyses; supports regulatory discussions with statistical input.Follows SOPs, WIs, and relevant regulatory guidelines (e.g., ICH); maintains organized project documentationCollaborates with others to meet business needs; prepares for internal meetings and respects colleagues’ opinions.Supports business development via proposals, budgets, and sponsor bid defenses.Performs other duties as assigned; minimal travel may be required.Benefits and Additional InformationWe offer benefits and a quality-of-life balance, including potential car or car allowance, medical/dental/vision, 401(k) with company match, Employee Stock Purchase Plan eligibility, performance-based incentives, and flexible PTO/sick time. Sick time eligibility varies by location and Syneos complies with applicable laws.Salary RangeThe base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary varies based on candidate qualifications and role proficiency.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, and supported 200+ studies across 73,000 sites and 675,000+ trial patients.We encourage you to apply even if your past experience doesn\u2019t align perfectly; transferable skills are considered. Learn more about Syneos Health at http://www.syneoshealth.com.Equal OpportunitySyneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status. If reasonable accommodations are needed during the application process, please contact us at jobs@syneoshealth.com. #J-18808-Ljbffr