Senior Clinical / Trial Biostatistician

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 Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.