Precision Medicine Group - Principal Biostatistician/Senior Principal Biostatistician

Remote - USA$147k - $147k2h ago

Remote Principal NA Clinical Research Principal Senior Researcher Documentation Client Consulting SAS Reporting Mentoring Decision Making

Requirements

• 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.)

Responsibilities

• Essential functions of the job include but are not limited to: • Consult with clients regarding clinical trial study design and regulatory strategy • Develop and review statistical methods of clinical study protocols • Provide and/or verify sample size calculations • Author statistical analysis plans of complex study design • Review statistical analysis plans written by other biostatisticians • Review statistical output to ensure accuracy • Review statistical sections of clinical study reports • Generate and/or verify randomization schedules • Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician • Work proactively with sponsors, internal study team, and external vendors • Serve as a Subject Matter Expert (SME) and develop/review procedural documents and work on new initiatives • Provide mentoring and training to other statisticians • Attend bid defense meetings for complex programs

Benefits

• Reasonable estimate of the current range • $147,300—$243,000 USD • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.