job specification

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

Nice to have

• Experience leading a Phase III oncology study from start-up