Principal Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the statistical design and analytical planning for oncology clinical utility studies.

• Offer technical expertise in sophisticated study design methodologies and data analyses.

• Suggest and substantiate efficient study designs customized for intricate oncology use cases.

• Act as the study statistician for Natera-sponsored studies and provide consultation for external partnerships.

• Collaborate with clinical, medical, and translational scientists in study planning, development, and execution.

• Identify potential risks, articulate concerns, and advocate for solutions to interdisciplinary teams and executive management.

• Draft and review statistical analysis plans, statistical reports, tables, listings, figures, clinical study reports, and publications.

• Recommend and implement innovative statistical methods.

• Mentor junior statisticians in their professional development.

• Contribute to the ongoing improvement of departmental processes, tools, and templates.

• Work collaboratively on publication manuscripts.

⛳️ Requirements

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• Over 15 years of experience in clinical trial biostatistics.

• Strong proficiency in time-to-event analysis, including management of censoring, competing risks, and advanced survival modeling techniques commonly applied in oncology.

• Expertise in innovative study design, encompassing adaptive and biomarker-informed designs, power calculations, and endpoint evaluations.

• Familiarity with ICH and GCP guidelines as well as CDISC standards, including SDTM and ADaM.

• Proficient in R programming.

• Exceptional ability to independently design clinical studies.

• Experience with biomarker-enabled clinical study designs, sample size calculations, and endpoint evaluations.

• Capable of thriving in fast-paced, cross-functional environments with collaborators from varied technical backgrounds.

• Adept at conveying complex statistical concepts clearly to both technical and non-technical audiences.

• Preferred: Familiarity with NGS-based diagnostics and ctDNA/MRD.

• Preferred: Experience with non-inferiority studies.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Pregnancy and baby bonding leave.

• 401k benefits.

• Commuter benefits.

• Employee referral program.