Lead Biostatistician, Oncology Trials (SAS, SAPs)

ClinChoice; Northern (KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

ClinChoice is seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio in oncology and beyond. You will lead statistical activities for clinical trials, author SAPs, ADS, and study reports, and collaborate with cross‑functional teams to ensure regulatory compliance.

The role requires hands‑on statistical expertise, excellent communication, and the ability to lead projects independently while mentoring junior statisticians and programmers

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field.
• Strong experience in Oncology studies.
• Hands‑on experience writing SAPs and ADS; reviewing analysis results.
• SAS programming skills required (hands‑on or strong working knowledge).
• Experience in CRO/pharma/biotech environments.

Responsibilities

• Lead and provide statistical support for clinical studies, primarily within Oncology.
• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables.
• Author and review SAPs, ADS, and statistical sections of clinical study reports.
• Review and interpret analysis outputs for accuracy, quality, and regulatory compliance.
• Collaborate with Clinical, Programming, Data Management, and Regulatory teams.
• Provide guidance and oversight to statistical programmers as needed.
• Communicate statistical concepts, results, and risks clearly to stakeholders.
• Ensure adherence to FDA, ICH, GCP and SOPs.

Skills

Oncology studies

Statistical leadership

Communication skills

Education

MS/PhD in Statistics or Biostatistics

Tools

SAS programming

Job description

ClinChoice is seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio in oncology and beyond. You will lead statistical activities for clinical trials, author SAPs, ADS, and study reports, and collaborate with cross‑functional teams to ensure regulatory compliance.

The role requires hands‑on statistical expertise, excellent communication, and the ability to lead projects independently while mentoring junior statisticians and programmers