ClinChoice

The Standard of Excellence

Principal Biostatistician Consultant – Oncology

Full TimeRemoteTeam 1,001-5,000Since 1998H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

9 days ago

Salary

Not specified

Postgraduate Degree8 yrs expEnglish

Job Description

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III). • Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs). • Design and review statistical methodologies for efficacy and safety analyses. • Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards. • Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs. • Collaborate with clinical development, data management, programming, regulatory, and medical teams. • Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA). • Provide strategic input on study design, endpoint selection, and sample size calculations. • Mentor junior statisticians and provide technical guidance.

Job Requirements

  • PhD or MS in Statistics, Biostatistics, or related field.
  • 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.
  • Strong experience in oncology clinical trials.
  • Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.
  • Proficiency in SAS and/or R.
  • Strong knowledge of CDISC standards (SDTM, ADaM).
  • Experience supporting regulatory submissions.
  • Excellent communication and leadership skills.

Benefits

  • Health insurance
  • Professional development opportunities

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