Senior Clinical / Trial Biostatistician

Saratoga Ascend; Oregon; Hybrid; USD 140,000 - 200,000; Full time

Job summary

Saratoga Medical is seeking a Remote, Senior Clinical / Trial Biostatistician to lead statistical aspects of complex clinical studies and regulatory submissions.

Ph.D. in biostatistics preferred; 8+ years experience (or 10 years with a Master's) including NIH/FDA-regulated trials; expertise in study design, analysis plans, DSMB tables, and proficiency in SAS and R.

Qualifications

• Ph.D. in biostatistics, statistics or related quantitative field preferred; master's degree with substantial equivalent experience acceptable.
• Minimum 8 years biostatistician experience on clinical studies (Ph.D.) or 10 years (master's), including NIH- or FDA-regulated trials.
• 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.

Skills

Clinical study design

Power and sample size calculations

Interim and final analyses

SAS

R

Regulatory submissions

Preclinical experience

NIH/FDA-regulated trials

GCP/HIPAA knowledge

CITI GCP training

Team collaboration

Education

Ph.D. in biostatistics or related field

Master's degree with substantial equivalent experience

Job description

Saratoga Medical is hiring a Remote, Senior Clinical / Trial Biostatistician.

Package includes competitive rate and benefit options.

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.