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

Principal Biostatistician RWE (NA Only) - with PASS (Post Authorization Safety Surveillance) Experience

The position is remote and requires the candidate to be located either in the US or Canada without needing sponsorship.

• Previous industry experience leading RWD studies is required.
• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develops training plans or materials for Biostatistics associates, conducts training sessions, and enhances the skills of existing personnel.
• Prepares Statistical Analysis Plans (SAPs), including development of mock‑up displays for tables, listings, and figures; collaborates with sponsor when required.
• 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, and provides independent review of project work produced by other statisticians.

• Randomized Controlled Trials (RCT)
• Clinical Trials (CT)
• Real‑World Data (RWD)

• Electronic Medical Records (eMR)
• Claims and Billing Data
• Patient Registries
• Patient‑Generated Data
• Pharmacy Data
• Device/Wearables

• Time‑to‑Event (TTE)
• Mixed Methods
• Regression
• Subgroup Analyses
• Sensitivity Analysis
• Missing Data Methods
• Machine Learning (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 Outcomes 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 focus.
• R will be important – packages such as matchit, mice (multiple imputation).
• SQL proficiency.
• Clarity and Health Variety data – Claims and eMR record merged.
• Primarily for marketing group: treatment patterns.
• Goal is to execute as well as guide the client.
• Free government data (requires extensive pre‑processing).
• Evaluation of data quality.
• Feasibility check for different databases.
• Sample‑size calculations.

• Extensive experience in clinical trials or equivalent combination of education and experience; demonstrated 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.

The benefits for this position may include a company car or car allowance, Health benefits (Medical, Dental and Vision), Company match 401(k), 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. 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.

$80,600.00 – $

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 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.