Join to apply for the Principal Biostatistician (RWE, HEOR) - North America, Europe role at Syneos Health.
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. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Discover what our 29,000 employees, across 110 countries already know.
What We Offer
* Passionate career development and progression.
* Supportive line management and technology training.
* Total Self culture of inclusion and belonging.
Job Responsibilities
* Experience with a variety of RWD including eHR, registry studies, pharmacy data, etc., as well as CT experience.
* Experience with RW safety studies including healthcare claims knowledge is critical.
* Required skills include: propensity score matching, estimands, logistic regression, survival analysis, incident rate understanding.
* Knowledge of safety assessments including disproportionality analyses, safety risk modeling, data mining and AI/ML, signal detection and other safety assessment skills will be useful.
* Serve as a statistical department resource, mentor biostatisticians, oversee training plans, conduct trainings.
* Prepare Statistical Analysis Plans (SAPs), develop mock‑up displays for tables and figures.
* Responsible for statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
* Review SAS annotated case report forms, SAS database design, and other study documentation.
* Create or review programming specifications for analysis datasets, tables, listings, and figures.
* Direct activities of other biostatistics personnel on assigned projects.
* Provide independent review of project work produced by other statisticians.
* Implement company objectives and create alternative solutions to challenges.
* Represent biostatistics on project teams, interface with other departmental representatives.
* Conduct verification and quality control of project deliverables.
* Manage scheduling and time constraints across multiple projects; communicate with management.
* Provide statistical programming support as needed.
* May participate in DSMB and DMC activities; may serve as voting statistician.
* Lead projects involving integrated analyses; attend regulatory agency meetings.
* Follow SOPs, WIs, and relevant regulatory guidelines.
* Maintain project documentation and verification/quality control documents.
* Support business development activities including proposals, budgets, and sponsor bid defense meetings.
* Perform other duties as assigned.
Required Qualifications
* Graduate degree in biostatistics or related discipline.
* Extensive experience in clinical trials or equivalent combination of education and experience.
* Proficiency in programming.
* Ability to apply statistical design, analysis, regulatory guidelines, and programming techniques.
* Experience with regulatory submissions preferred.
* Excellent written and verbal communication skills.
* Fluency in English.
Preferred Qualifications
* Additional experience in RWE/HEOR and medical affairs.
* Experience with healthcare claims data, eHR, registries, pharmacy datasets.
* Knowledge of AI/ML methods in safety assessment.
Benefits
* Company car or car allowance.
* Health benefits: medical, dental, vision.
* Company match 401(k).
* Employee Stock Purchase Plan eligibility.
* Bonus/commission compensation.
* Flexible paid time off (PTO) and sick time.
Salary Range
$95,000.00 - $175,700.00
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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