Precision for Medicine - Principal Biostatistician/Senior Principal Biostatistician

• Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience • Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience • Broad experience with regulatory submissions • Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy • Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures) • Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Experience with SAS • Experience with oncology and rare diseases • Experience with DMCs • Excellent communication and interpersonal skills • Excellent problem-solving skills • Excellent presentation skills • Excellent organizational and time management skills • Outstanding statistical skills • Competencies: • Sound judgment/decision making • Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients • Service oriented, accountable, and flexible • Competency in written and spoken English • Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures • At all times to promote the image of Precision, acting as an ambassador to the Company • Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)