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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 statistical analysis plans for complex study designs, and reviewing statistical analyses and results.
Key responsibilities include consulting with clients on clinical trial design and regulatory strategy; developing and reviewing statistical methods for clinical study protocols; providing and verifying sample size calculations; authoring statistical analysis plans for complex studies; reviewing SAPs written by other biostatisticians; reviewing statistical output for accuracy; reviewing statistical sections of clinical study reports; generating and verifying randomization schedules; providing statistical analysis and reporting to Data Monitoring Committees as the unblinded reporting biostatistician; working proactively with sponsors, internal teams, and external vendors; serving as a subject matter expert in areas such as Bayesian adaptive design, survival analysis, or DMCs; developing and reviewing procedural documents; mentoring and training other statisticians; and attending bid defense meetings for complex programs.
Required qualifications: For Principal level, a Master's degree in Statistics, Biostatistics, or related field with 10+ years of experience, or a PhD with 7+ years of experience. For Senior Principal level, a Master's degree with 12+ years of experience or a PhD with 9+ years of experience. Candidates must have broad experience with regulatory submissions, extensive experience consulting on clinical trial design and regulatory strategy, superior understanding of statistical methodology (Bayesian adaptive design, survival analysis, repeated measures), sound knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines, and experience with SAS.
Preferred qualifications include experience with oncology and rare diseases, Data Monitoring Committee experience, excellent communication and interpersonal skills, problem-solving abilities, presentation skills, organizational and time management skills, and outstanding statistical expertise. The role requires sound judgment, ability to establish effective working relationships, service orientation, accountability, flexibility, competency in written and spoken English, and commitment to regulatory compliance and company values.
