[Hiring] Principal Biostatistician RWE @Syneos Health

Role Description

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

• Must be located in US or Canada with no sponsorship needs to be considered for this remote role.
• 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, or otherwise trains new hires and enhances the skills of existing personnel.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Collaborates with sponsor, if 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.
• Provides independent review of project work produced by other statisticians in the department.

Qualifications

• Experience with RCT, CT, RWD.
• RWD experience, including but not limited to:
  • eMR
  • Claims and Billing Data
  • Patient registries
  • Patient-Generated Data
  • Pharmacy Data
  • Device/Wearables
• General Statistics, TTE, Mixed Methods, Regression, Subgroup analyses, Sensitivity Analysis, Missing data methods, ML, Predictive Modeling, Meta-analysis, Neural network analysis, Cluster analysis.
• RWE analysis experience, including but not limited to:
  • 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

Requirements

• 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.

Benefits

• 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.
• Flexible paid time off (PTO) and sick time.

Salary Range

$80,600.00 - $175,700.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.