Senior Clinical, Trial Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support for clinical studies in the role of a senior clinical/trial biostatistician.

• Design clinical trials, including those for small populations and early-phase studies.

• Create statistical analysis plans and randomization schemes.

• Conduct power and sample size calculations.

• Execute interim and final analyses.

• Generate tables, listings, and figures for DSMB reviews and regulatory submissions.

• Assist with preclinical studies.

• Contribute to the development of protocols, reports, and manuscripts.

• Support clinical research programs regulated by the NIH or FDA.

• Collaborate with Government clinical investigators, regulatory personnel, and program officials within a multidisciplinary team.

⛳️ Requirements

• A Ph.D. in biostatistics, statistics, or a related quantitative field is preferred.

• A Master's degree with significant equivalent experience is acceptable.

• At least 8 years of experience as a biostatistician in clinical studies (Ph.D.) or 10 years (Master's), including work on NIH- or FDA-regulated trials.

• Experience in clinical study design, particularly for small populations and early-phase studies.

• Expertise in developing statistical analysis plans and randomization schemes.

• Proficiency in conducting power and sample size calculations.

• Experience with interim and final analyses and the production of tables, listings, and figures for DSMB reviews and regulatory submissions.

• Strong skills in SAS, R, or comparable statistical software.

• Background in supporting preclinical studies and contributing to protocols, reports, and manuscripts.

• A minimum of five years of direct experience in supporting NIH or FDA-regulated clinical research programs.

• Familiarity with Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 (as applicable), 45 CFR Part 46, and HIPAA.

• Current training in human subjects protections and GCP (e.g., CITI or equivalent).

• Proven ability to work within a multidisciplinary team alongside Government clinical investigators, regulatory staff, and program officials.

🏝️ Benefits

• Competitive compensation package.

• Various benefit options available.

• Commitment to equal opportunity employment.