Precision for Medicine - Principal Biostatistician
Requirements
• 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 • Experience with SAS • Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Broad knowledge and superior understanding of advanced statistical concepts and techniques • Preferred: • Experience with Oncology and rare diseases • Broad experience with late phase and/or submissions • Experience in consulting with clients on study design • Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data) • Mastery of statistical principles underlying clinical trials • Mastery of SAS programming skills and familiarity with other packages • Outstanding statistical skills • Excellent consultative skills • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines. • Excellent communication and interpersonal skills to effectively interface with others. • Excellent problem-solving skills • Excellent presentation 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 • 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.
Responsibilities
• Essential functions of the job include but are not limited to: • Generate and/or verify randomization schedules • Develop and review statistical methods of the clinical study protocol including complex study designs • Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design • Provide input into development of case report forms (CRFs) • Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase • Review statistical analysis plans written by other biostatisticians • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS • Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports) • Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests • Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives • Review output across programs to ensure consistency. • Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician • Review statistical sections of clinical study reports • Work directly with sponsors, project managers, and external vendors on statistics related project components. Interact directly with study team • Interact directly with sponsors • Lead all statistical activities for study within timelines • Independently perform budget health review on projects and review monthly invoices • Assist with budget development and present at bid defense meetings • Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.) • Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope
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