Precision Medicine Group
New York City, New York, United States, NY
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, and 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
- Review statistical methods of the clinical study protocol
- Provide and/or verify sample size calculations
- Provide input into development of case report forms (CRFs)
- Author statistical analysis plans, including development of table, figure and listing shells.
- 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 programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Perform statistical consulting tasks with some senior oversight
- 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
- Assist with budget health review on projects and review monthly invoices
- Perform oversight responsibilities on projects for new 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
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 4+ years experience; PhD degree in Statistics, Biostatistics, or related field with 2+ years experience
- Experience with SAS
- Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Knowledge of advanced clinical trial design concepts and advanced statistical methodologies
- Experience with Oncology and rare diseases
- Experience with late phase and/or submissions
- Experience in consulting with clients on study design
- Understanding of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
- Understanding of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data
- 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
- Sound judgment/decision making
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Service oriented, accountable and flexible
- Competency in written and spoken English
- Follow 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.)