Senior Biostatistician, Oncology (Solid Tumors)

ClinChoice; United States; On-site; USD 180,000 - 230,000; Full time

Job summary

ClinChoice is seeking a Principal Biostatistician Consultant – Oncology (Solid Tumors) to provide statistical leadership across oncology clinical trials. You will design, analyze, and interpret trials, contribute to SAPs and CSRs, and collaborate with cross-functional teams to ensure regulatory-ready statistical deliverables.

The role requires deep expertise in solid tumor endpoints, time-to-event analyses, and CDISC standards, with strong mentorship and communication skills to guide junior

Qualifications

• PhD or Master's degree in Biostatistics, Statistics, or related quantitative discipline.
• Extensive experience in clinical development within pharma/biotech.
• Strong Biostatistician background in oncology clinical trials (solid tumors).
• Experience in Phase I–III trial design, analysis and reporting.
• Knowledge of oncology endpoints: OS, PFS, ORR, DoR, DCR.
• Survival analysis expertise: Kaplan–Meier, Cox, log-rank.
• Experience developing protocols, SAPs, and sections of CSRs.
• Knowledge of CDISC standards (CDASH/ADaM) and regulatory submissions.
• Proficiency in SAS and/or R for statistical analysis.
• Experience leading cross-functional clinical development teams.
• Excellent communication, presentation, and problem-solving skills.

Responsibilities

• Provide statistical leadership in oncology trial design and execution.
• Lead development of protocols, SAPs, and other statistical documents.
• Provide input on trial design across Phases I–III.
• Develop methodologies for oncology endpoints (OS, PFS, ORR, DoR, DCR).
• Apply time-to-event methods and survival analysis techniques.
• Contribute to interim analyses, sample size and adaptive designs.
• Oversee statistical analyses and ensure quality of outputs (TFLs).
• Collaborate with statistical programmers for ADaM datasets and TFLs.
• Interpret trial results for CSRs, regulatory submissions, and publications.
• Mentor junior statisticians and cross-functional teammates.
• Ensure compliance with ICH-GCP and industry standards.

Skills

Oncology biostatistics

Survival analysis

CDISC (CDASH/ADaM)

SAS

R

Clinical trial design

Regulatory understanding

Cross-functional leadership

Communication & presentation

Education

PhD or MS in Biostatistics

Tools

SAS

R

Job description

ClinChoice is seeking a Principal Biostatistician Consultant – Oncology (Solid Tumors) to provide statistical leadership across oncology clinical trials. You will design, analyze, and interpret trials, contribute to SAPs and CSRs, and collaborate with cross-functional teams to ensure regulatory-ready statistical deliverables.

The role requires deep expertise in solid tumor endpoints, time-to-event analyses, and CDISC standards, with strong mentorship and communication skills to guide junior