Natera izstrādā uz šūnām nebalstītas DNS pārbaudes un bioinformātikas risinājumus veselības aprūpei. Tās diagnostikas tehnoloģijas atbalsta neinvazīvu prenatālo skrīningu, vēža noteikšanu un orgānu transplantācijas uzraudzību, palīdzot ārstiem un pacientiem izmantot ģenētisko informāciju, lai pieņemtu pamatotākus lēmumus par aprūpi. Uzņēmuma darbā apvienojas biotehnoloģija, datu analīze un klīniskie lietojumi vairākās mūsdienu medicīnas jomās.
Staff Biostatistician, Clinical Validation
Lead regulated clinical validation studies for Natera’s cell-free DNA diagnostic tests. Design statistical analyses and support FDA submissions across kidney disease and germline projects.
Apraksts
- Lead the design, analysis, and interpretation of clinical validation studies for in vitro diagnostic approvals, including companion diagnostic, 510(k), and PMA submissions.
- Ensure statistical methods and analyses comply with FDA and other regulatory agency standards.
- Lead statistical discussions with regulatory authorities.
- Prepare statistical analysis protocols, reports, and presentations for internal teams and external collaborators.
- Act as statistical lead for high-priority project teams.
- Coordinate project planning and execution with Clinical Science, Data Management, and Product teams.
- Identify risks, raise concerns, and guide interdisciplinary teams toward solutions.
- Lead the design and execution of clinical trials, studies, and publications.
- Apply new biostatistical and clinical validation methods to diagnostic product development and regulatory submissions.
- Mentor junior colleagues and provide technical supervision.
Prasības
- PhD or master's degree in biostatistics, statistics, or a related discipline.
- At least eight years of relevant industry experience, preferably in molecular diagnostics, biotechnology, or a related field.
- Experience working in regulated settings, including prior companion diagnostic or in vitro diagnostic submissions.
- Experience with next-generation sequencing, genetic, or germline data.
- At least four years of practical experience using R for statistical analysis.
- Expertise in statistical methods for diagnostic medicine and familiarity with FDA guidance.
- Experience engaging with regulatory bodies such as the FDA.
- Ability and willingness to work across teams with varied technical expertise.
- A strong record of producing high-quality written materials for different audiences.
- Germline assay development experience preferred.
- Kidney disease experience desired.
- Experience designing and analyzing clinical validation studies.
- Strong communication skills, including explaining complex statistical concepts to non-statistical audiences.
- Careful attention to detail and a commitment to high-quality work under tight deadlines.
Priekšrocības
- Medical, dental, vision, life, and disability plans for eligible employees and dependents.
- Free testing for employees and their immediate families.
- Fertility care benefits.
- Pregnancy and baby-bonding leave.
- 401(k) benefits.
- Commuter benefits.
- Employee referral program.