Master's (MS) degree in statistics, biostatistics, mathematics, or related field; at least 2 years of experience as a clinical trial statistician within an academic center, clinical data management organization, pharmaceutical company, or clinical research organization (CRO). Understands clinical research. Learns new IT systems quickly, including eTMF. Ability to multitask, prioritize, negotiate, analyze and solve problems, manage competing priorities, meet timelines, and work independently are required. Excellent communication skills, ability to work within a cross-functional team, and strong attention to detail are expected.
Other qualifications include:
- Knowledge of statistical theory and methods for biomedical research
- Experience working on statistical deliverables such as statistical sections of clinical protocols, statistical analysis plans (SAPs), and creation and validation of statistical programs
- Understanding of SDTM and ADaM CDISC standards
- Prior experience of collaboration with data management in ensuring quality in data collection, aggregation, and analysis
- Working knowledge of SAS. Knowledge of R is a plus
- Ensures Trialwise standard operating procedures are followed and that appropriate project documentation is ongoing.
- Ensures timely, accurate, and complete filing of biostatistics trial documents in accordance with the TMF Master Index, the TMF Plan, SOPs, and any other documented conventions.
- Supports integrated eTMF workflows for biostatistics trial documents including a quality review of biostatistics trial documents prior to approval and filing.
- Provides randomization schemes and appropriate documentation.
- Provides sample size calculations and justification in study protocols.
- Coordinates with programmers and data management personnel regarding database maintenance, updating, and documentation.
- Writes and reviews Statistical Analysis Plans (SAPs) and table, figure, and listing (TLFs) shells.
- Works with the programmers to create and review specifications for SDTM and ADaM datasets.
- Programs/validates statistical tables and figures with an emphasis on protocol defined endpoints.
- Provides proper documentation and oversees the work of others who assist in programming/validating.
- Reviews the define.xml, annotated CRFs, data reviewer guides, and Pinnacle 21 reports.
- Prepares and reviews statistical reports.
- Contributes to the statistical methods sections of protocols and/or clinical study reports, assists with statistical interpretation of study data, and verifies information for completeness and consistency.
- Assists the programmers in developing tools to help automate and simplify work processes within the biometrics area.
- Interacts with and supports other Trialwise personnel to fulfill project role and achieve project goals.
Reports to the functional area manager for biostatistics. Supports a senior biostatistician or performs statistical project activities under the supervision of a senior biostatistician. Travels up to twice annually for team meetings or conferences.
Looks for opportunities to expand breadth and depth of statistical and data programming, computer software, and/or clinical research experience. Assists the cross-functional team when possible. Provides outstanding customer service to Trialwise clients. Maintains a positive outlook and a growth mindset in all work activities.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
Foster City, CA or US remote-based (home office) with travel as required.
$85,000–$105,000 based on experience