8h ago
Senior/Staff Statistician, Assay Development
Palo Alto, CA
$150k-$215k / year
full-timesenior Hybridbiotech
๐ Tech Stack
๐ผ About This Role
You'll provide statistical leadership for analytical validation studies of NGS-based liquid biopsy assays at a diagnostics company pioneering accessible cancer screening. Your work directly supports regulatory submissions that can save lives globally.
๐ฏ What You'll Do
- Design and execute analytical validation studies for cancer detection assays.
- Apply statistical methods for NGS-based and liquid biopsy platforms.
- Author statistical analysis plans, study reports, and regulatory submissions.
- Serve as internal statistical consultant across functions and mentor junior team members.
๐ Requirements
- Doctoral degree in Statistics, Biostatistics, or related field with 2+ years industry experience; or Master's with 5+ years.
- Experience designing and analyzing applied statistical studies in analytical validation.
- Proficiency in R (Python is a plus).
- Assay validation experience in a regulated environment (LDT or IVD) and familiarity with CLSI guidelines.
โจ Nice to Have
- Experience with NGS-based assays or liquid biopsy platforms.
- Experience with FDA pre-submission meetings or direct agency interactions.
- Ability to develop novel statistical methods from first principles.
๐ Benefits & Perks
- ๐๏ธ Unlimited PTO
- ๐ฅ Comprehensive health insurance
- ๐ Equity grants
- ๐ป Remote-friendly culture
๐จ Hiring Process
Estimated timeline: 3-5 weeks ยท AI estimate
- 1Recruiter phone screenยท 30 min
- 2Hiring manager interviewยท 45 min
- 3Technical interviewยท 60 min
- 4Onsite (or virtual) panelยท 3 hours
- 5References and offerยท 1 week
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