Senior Biostatistician - Non-Clinical
Proclinical is currently recruiting for a Senior Non-Clinical Biostatistician with a leading precision medicine solutions company located in South San Francisco, CA. Successful candidate will be responsible for applying statistical techniques in the non-clinical validation and verification of processes in the lab.
- Provide statistical guidance to various projects and initiatives throughout the company.
- Have key interfaces beyond R&D with personnel involved in clinical research, clinical informatics, commercial laboratory operations, manufacturing, engineering, and software development.
- Consult with research and development labs, commercial lab and clinical development and recommend appropriate experimental design methods and statistical techniques.
- Contribute statistical expertise and guidance to studies conducted by the clinical, research, development, and clinical reference laboratory groups.
- Verify and Validate lab processes and assay validation.
- Laboratory process development and validation.
- Expert in initiating new lab and equipment processes.
Skills and Requirements:
- PhD Preferred, but MS required in statistics, mathematics, computational methods, or a related discipline or equivalent experience. Additional training or degree in biochemistry, molecular biology, or immunology would be considered an added benefit.
- 5+ years of experience working in the in vitro diagnostics field (LDT and/or FDA regulated).
- Expert in R, SAS and other statistical software packages.
- Expert in non-clinical work.
- CLSI certified preferred. (Clinical Laboratory Standards Institute).
- Experience using diverse and fit-for-purpose experimental design techniques required.
- Strong desire and proven ability to work collaboratively and cross functionally on new product development teams, departmental projects, and company initiatives.
- Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains. The desire and ability to communicate and mentor company staff in basic statistics.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.