Anaheim, CA 92801
Greater Los Angeles area
$130k - $150k salary range
Nihar Parikh - [email protected]
This is a great opportunity to join a midsize biotech that plans to double in size in the next few years and offers an entrepreneurial environment, great work life balance, and visibility to leadership.
In this role you will serve as the SME for statistical methodology and provide the organization with guidance on regulatory compliance, study design plans, clinical validation, product development and research.
Develop statistical procedures for regulatory submissions, publications, and process improvements.
Establish statistical methodology on product development, clinical and analytical studies, validations, and process improvements.
Partner with cross functional teams on technical topics and communicate statistical issues.
Degree in Biostatistics, Mathematics, Statistics, or related field. Advanced degree a plus.
Seeking candidates with pharmaceutical industry experience and expertise with statistical analysis plans, clinical development, regulatory guidelines, technical standards and SAS programming.
Experience in clinical trial design, FDA regulations, product development and statistical methodologies.
Proficiency with data collection, data mining techniques, statistical quality control and the ability to draw conclusions based on analysis.
Must be comfortable working independently with limited supervision.
Smith Hanley Associates is a niche recruiting agency. Please visit our website at www.smithhannley.com