Saratoga Medical is hiring a
Remote, Senior Clinical / Trial Biostatistician Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
Education: Ph.D. in biostatistics, statistics or a related quantitative field preferred; master's degree with substantial equivalent experience acceptable.
Experience: Minimum of 8 years of experience as a biostatistician on clinical studies (Ph.D.) or 10 years (master's), including NIH- or FDA-regulated trials.
Qualifications:- Clinical study design, including small-population and early-phase designs
- Development of statistical analysis plans and randomization schemes
- Power and sample size calculations
- Interim and final analyses, and production of tables, listings and figures for DSMB reviews and regulatory submissions
- Proficiency in SAS, R or equivalent statistical software
- Experience supporting preclinical studies and contributing to protocols, reports and manuscripts
- Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
- Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
- Current human subjects protections and GCP training (e.g., CITI or equivalent)
- Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials
