Syneos Health

Principal Biostatistician, Safety Surveillance, RWE

Syneos Health

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $95,000 - $175,700 per year

Job Level

Lead

About the role

  • Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates.
  • Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
  • 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.
  • Implements company objectives, and create alternative solutions to address business and operational challenges.
  • Serves as biostatistics representative on project teams.
  • Conducts and participates in verification and quality control of project deliverables.
  • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes, and proactively communicates difficulties with timelines to management.
  • Provides statistical programming support as needed.
  • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
  • Leads projects involving integrated analyses, attends regulatory agency meetings or respond to questions, as needed.
  • Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines.
  • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs.
  • Displays willingness to work with others and assists with projects and initiatives as necessary.
  • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required.

Requirements

  • Experience with RW safety studies including healthcare claims knowledge is critical.
  • Required skills include: propensity score matching, knowledge and use of estimands, logistic regression, survival analysis, incident rate understanding etc.
  • Knowledge of Safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining and AI/ML, signal detection and other safety assessment skills will be useful skills.
  • Graduate degree in biostatistics or related discipline.
  • 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.