Senior Biostatistician - Phase III Oncology (Remote)

Greenhouse Software, Inc.

Northern (KY)

Hybrid

USD 120,000 - 190,000

Full time

3 days ago
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Job summary

ClinChoice is seeking a Senior/Principal Biostatistician to support Phase III oncology trials remotely, delivering statistical analyses, creating TFLs, and contributing to ADaM specifications in collaboration with Statistical Programming.

Ideal candidates hold an MS/PhD in statistics, have hands-on Phase III oncology experience, and are proficient in OS, PFS, ORR, DoR, censoring, Kaplan-Meier, Cox models, and SAS; strong communication and independence are essential.

Qualifications

  • Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative field.
  • Direct hands-on experience supporting at least one Phase III oncology clinical trial.
  • Strong understanding of oncology clinical trial endpoints, including OS, PFS, ORR, and DoR.
  • Strong knowledge of censoring rules and time-to-event analysis.
  • Hands-on experience with Kaplan-Meier, Cox Proportional Hazards, and stratified log-rank methods.
  • Strong SAS programming skills with the ability to review statistical programming outputs and perform independent checks.
  • Experience authoring or reviewing TFL and ADaM specifications and collaborating closely with Statistical Programming.
  • Strong problem-solving skills with the ability to identify and resolve discrepancies in analysis outputs.
  • Ability to work independently, quickly onboard to new studies, and operate effectively with minimal supervision.
  • Demonstrated ability to manage deliverables across multiple concurrent clinical trials while maintaining quality and timelines.
  • Excellent written and verbal communication skills.

Responsibilities

  • Provide statistical expertise and hands-on support for Phase III oncology clinical trials.
  • Contribute to study design, statistical analysis, interpretation of results, and clinical study deliverables.
  • Demonstrate a strong understanding of key oncology endpoints, including OS, PFS, ORR, and DoR.
  • Apply and interpret methods for censoring and time-to-event analyses.
  • Author, review, and provide input into TFL and ADaM specifications in collaboration with Statistical Programming.
  • Review statistical programming outputs, identify discrepancies, and work with programmers to resolve issues.
  • Use SAS to independently review outputs and perform data and analysis checks.
  • Manage deliverables across multiple concurrent clinical studies, ensuring timelines and quality.
  • Work independently with minimal supervision and collaborate with cross-functional teams as required.
  • Support interim analyses and IDMC/DMC activities, including preparation and review of DMC outputs.

Skills

Independent work
Strong communication
Cross-functional collaboration
Statistical design
Problem solving

Education

MS/PhD in Statistics or Biostatistics

Tools

SAS
R

Job description

ClinChoice is seeking a Senior/Principal Biostatistician to support Phase III oncology trials remotely, delivering statistical analyses, creating TFLs, and contributing to ADaM specifications in collaboration with Statistical Programming.

Ideal candidates hold an MS/PhD in statistics, have hands-on Phase III oncology experience, and are proficient in OS, PFS, ORR, DoR, censoring, Kaplan-Meier, Cox models, and SAS; strong communication and independence are essential.

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