Principal Biostatistician RWE; NA - PASS; Post Authorization Safety Surveillance Ex

Job Responsibilities

• Must be located in the U.S. or Canada with no sponsorship needed for this remote role.
• Previous industry experience leading RWD studies is required.
• Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans or materials for Biostatistics associates. Conduct training sessions or otherwise train new hires and enhance the skills of existing personnel.
• Prepare Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Collaborate with sponsor, if required.
• Be responsible for the statistical aspects of the protocol, including generation of randomization schedules and input to the clinical study report.
• Review 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.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work. Provide independent review of project work produced by other statisticians in the department.

• RCT
• CT
• RWD

• eMR
• Claims and Billing Data
• Patient registries
• Patient-Generated Data
• Pharmacy Data
• Device/Wearables

• TTE
• Mixed Methods
• Regression
• Subgroup analyses
• Sensitivity Analysis
• Missing data methods
• ML
• Predictive Modeling
• Meta-analysis
• Neural network analysis
• Cluster analysis

• Comparative Effectiveness Research
• Exploratory Data Analysis including descriptive statistics
• Propensity Score Matching
• Causal Inference
• Health Economics and Outcome Research (HEOR)
• Country specific Dossiers
• Risk modeling
• Signal detection
• Biomarker trends
• Interrupted Time Series Analysis
• Network Meta-Analyses using RWD

• Fast growing
• HEOR, HTA, cost effectiveness
• R will be important – matchit, mice (multiple imputation)
• SQL
• Clarity and Health Variety data (Claims and eMR record merged)
• Goal is to execute as well as guide the client
• Free government data – a lot of pre‑processing
• Evaluation of data quality
• Feasibility check for different databases
• Sample size calculations

• 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.

$80,600.00 – $

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. The benefits for this position may include a company car or car allowance, 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, and flexible paid time off (PTO) and sick time.

Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state and municipal paid sick time requirements.

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 job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

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.