Job Description
Alsinova is looking for a Principal Biostatistician to lead statistical activities on a pivotal Phase III oncology study. This is a hands-on leadership role on sponsor side. The position is remote on US time zone.
Responsibilities
- Lead all statistical deliverables from study start-up through database lock (SAP, TLF specs, analysis oversight)
- Contribute to protocol design, randomization, and sample size planning (ICH E9(R1))
- Provide statistical review of regulatory documents and support CSR/submission activities
- Mentor junior biostatisticians and programmers as needed
Requirements
- MSc or PhD in Statistics or Biostatistics
- Substantial oncology clinical trial experience with direct ownership of Phase II/III studies
- Strong delivery skills in fast-paced environments
- Solid knowledge of oncology endpoints (OS, PFS, ORR, RECIST) and FDA/EMA guidelines