[Hiring] Principal Biostatistician @Precision Medicine Group

Role Description

Provides statistical support for all phases of clinical development. Specific responsibilities include:

• Writing and reviewing statistical sections of protocols
• Writing and reviewing statistical analysis plans including complex study designs
• Conducting statistical analyses and presenting results to project teams and sponsors
• Developing SAS programs for tables, listings, figures, and analysis datasets in accordance with Precision and/or sponsor procedures or study-specific guidelines

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 and sponsors
• Lead all statistical activities for study within timelines
• Independently perform budget health review on projects and review monthly invoices
• Perform oversight responsibilities on projects for other biostatisticians
• 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
• Other duties as assigned

Qualifications

• Minimum Required: 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
• Other Required: 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 (e.g., adaptive design, missing data)

Requirements

• 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