Syneos Health

Senior Biostatistician, Oncology

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: California • Florida • United States

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Job Level

Senior

About the role

  • Leading projects across multiple studies or programs
  • Acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects
  • Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR
  • Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures
  • Collaborates with the sponsor, if required
  • May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report
  • Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work
  • Provides independent review of project work produced by other biostatisticians in the department
  • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
  • Reviews SAS annotated case report forms (CRFs), 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
  • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications
  • Implements company objectives, and create alternative solutions to address business and operational challenges
  • Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives
  • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management
  • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met
  • Identifies out of scope tasks and escalates to management
  • Provides statistical programming support as needed
  • May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician
  • May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor
  • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness
  • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business
  • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings
  • Coaches and mentors other Biostatistics staff.
  • Performs other work-related duties as assigned.

Requirements

  • MS required, PhD preferred
  • TA: Oncology is expected
  • Phase experience: Pre-clinical, Phase I-IIab PK/PD is a nice to have
  • Lead experience is a plus
  • Interacting with the team
  • Directing the work of others
  • Able to quickly adapt and deliver
  • Study design experience: BOIN, since that is what most of them are
  • Endpoints: mainly overall response, PFS as secondary, some biomarkers
  • Running simulations and supporting design alternatives
  • Output review
  • Familiarity with SDTM/ADaM datasets (not programming them, just using them for output review, knowing which ones are for what)
  • IB authoring, DSUR reviews
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Statistical Analysis Plans (SAPs)SAS programmingBiostatisticsStatistical programmingData Safety Monitoring BoardData Monitoring CommitteeStudy designSimulation runningOutput reviewIB authoring
Soft Skills
LeadershipCollaborationCoachingMentoringAdaptabilityCommunicationProject managementQuality controlProblem-solvingInterpersonal skills
Certifications
MSPhD