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:
- 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
- Other duties as assigned.
Qualifications:
- 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
Other Required:
- 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
Preferred:
- Experience with Oncology and rare diseases
- Experience with late phase and/or submissions
- Experience in consulting with clients on study design
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