Senior Director, Biostatistics — Oncology & Neuro Leader

LeonaBio, Inc.; Bothell (WA); On-site; USD 270,000 - 290,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with employer match

PTO 25 days + 11 holidays

Job summary

LeonaBio, Inc. in the Seattle area is seeking a Senior Director, Biostatistics to lead statistical strategy across the drug development lifecycle.

You will partner with Clinical Development, Regulatory, Data Management, and other teams to shape study design and interpretation of results. The ideal candidate has 10+ years in biostatistics within biotech/pharma, strong expertise in oncology/neurology or related diseases, and a track record in regulatory submissions and external partner management.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years of biostatistics experience in pharma/biotech/CRO with leadership in clinical development.

Responsibilities

• Provide statistical leadership across clinical development programs including study design, endpoint selection, sample size and power, randomization and analysis strategy.
• Lead or oversee statistical analyses and deliverables across trials (TLFs, CSR, etc.) and support regulatory submissions.
• Provide statistical input for regulatory interactions and health authority questions; prepare statistical sections and briefing materials.
• Oversee external biostatistics partners/CROs and manage resources and timelines.

Skills

Biostatistics leadership

Clinical development

Regulatory submissions

Statistical design

SAS and/or R

CDISC SDTM/ADaM

Education

PhD or MS in Biostatistics

Tools

SAS

R

Job description

LeonaBio, Inc. in the Seattle area is seeking a Senior Director, Biostatistics to lead statistical strategy across the drug development lifecycle.

You will partner with Clinical Development, Regulatory, Data Management, and other teams to shape study design and interpretation of results. The ideal candidate has 10+ years in biostatistics within biotech/pharma, strong expertise in oncology/neurology or related diseases, and a track record in regulatory submissions and external partner management.