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Precision for Medicine seeks a Principal or Senior Principal Biostatistician to provide statistical leadership and support across all phases of clinical development. This is a senior individual contributor role focused on consulting with clients on clinical trial study design and regulatory strategy, authoring and reviewing statistical methods sections of protocols, developing complex statistical analysis plans, and serving as a subject matter expert in specialized areas such as Bayesian adaptive design, survival analysis, or data monitoring committees.
Key responsibilities include: consulting on clinical trial design and regulatory strategy; developing and reviewing statistical methodologies for study protocols; performing and verifying sample size calculations; authoring statistical analysis plans for complex studies; reviewing analyses and statistical output for accuracy; generating randomization schedules; providing unblinded statistical reporting to Data Monitoring Committees; mentoring junior statisticians; and serving as a subject matter expert on procedural documents and new initiatives. You will work proactively with sponsors, internal teams, and external vendors, and attend bid defense meetings for complex programs.
Minimum qualifications: Master's degree in Statistics, Biostatistics, or related field with 10+ years of experience (or PhD with 7+ years); or Master's with 12+ years (or PhD with 9+ years) for Senior Principal level. Required expertise includes broad regulatory submission experience, extensive client consulting on trial design, superior understanding of advanced statistical methodologies, knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, FDA guidelines, and SAS proficiency. Preferred qualifications include oncology and rare disease experience, DMC involvement, and excellent communication, problem-solving, and presentation skills.
