Palo Alto, CA 94304
San Francisco Bay Area, CA
Nihar Parikh - [email protected]
Oversee statistical aspects of study design, analysis, validation and study documentation as well as programming with external vendors.
-Provide statistical expertise to clinical development projects.
-Develop statistical analysis plans, perform data analysis and validation.
-Manage CRO's, assist in the publication of study data.
-Develop and validate data systems and work with teams from data management and clinical operations and analysis.
-Provide clinical study design and analysis strategies.
-MS or PhD in Biostatistics, Mathematics, or similar field required.
-Proficiency with statistical analysis, clinical programs, drug development guidelines, and regulatory submissions.
-Pharmaceutical background and experience in clinical trials.
-Experience with SAS programming, CDISC models, and data standards.
-Experience contributing to NDA/BLA's and supporting publications.