Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Principal Biostatistician, RWE, Commercial DBs

Clinical ResearchClinical ResearchFull TimeRemoteTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

New Jersey + 4 moreAll locations: New Jersey, New York, Massachusetts, South Carolina, Texas

Posted

25 days ago

Salary

Not specified

Postgraduate DegreeEnglish

Job Description

• 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

Job Requirements

  • 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

Benefits

  • 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

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