Conduct data integrity reviews to ensure accuracy and traceability of data used in analyses
Verify statistical output by conducting various analyses and visualizations to confirm accuracy
Provide analysis, modeling, and visualizations of data from scientific studies
Analyze laboratory data to assess stability of drug substance and drug product
Create stability graphs suitable for regulatory submission documents
Compile/format data from one or more data sources
Conduct testing of automation tools
Co-author technical reports
Prepare Statistical Analysis Plans (SAPs)
Responsible for the statistical aspects of the protocol
Reviews SAS annotated case report forms and other study documentation
Creates or reviews programming specifications for datasets, tables, listings, and figures
Directs the activities of other biostatistics personnel on assigned projects
Conducts verification and quality control of project deliverables
Provides statistical programming support as needed
Prepares for internal meetings and demonstrates respect for opinions of others
Supports business development activities

Experience in the application of statistics in product development or manufacturing
Excellent English communication skills, especially related to technical/scientific issues
Proficient in R and JMP, data acquisition/compilation across sources
Interpersonal/teamwork and communications skills for effective collaboration
Strong teamwork skills
Self-management skills
Degree in or strong desire to learn about chemistry, biology, engineering, and pharmaceutical science
Graduate degree in biostatistics or related discipline
Extensive experience in clinical trials or an equivalent combination of education and experience

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

Principal Biostatistician, RWE, Commercial DBs

Key skills