Job Summary: We are seeking a highly skilled and experienced Statistical Programmer to join our client's dynamic team. The successful candidate will play a critical role in the programming and analysis of clinical trials and other research studies, with a specific focus on diabetes. This position requires strong programming skills, attention to detail, and the ability to work collaboratively with cross-functional teams. The role offers a hybrid working arrangement, requiring onsite presence in the San Francisco area.
Key Responsibilities:
- Programming: Develop and maintain SAS programs to analyze clinical trial data, generate tables, listings, and figures, and create datasets.
- Data Management: Collaborate with data management teams to ensure accurate and efficient data collection, cleaning, and validation processes.
- Statistical Analysis: Support biostatisticians in performing complex statistical analyses by providing well-documented and validated programs.
- Study Design: Assist in the design of clinical trials and observational studies, including the development of statistical analysis plans.
- Reporting: Prepare detailed statistical reports, including summary statistics, inferential statistics, and graphical representations of data.
- Collaboration: Work closely with clinical researchers, data managers, and other stakeholders to provide programming expertise and support throughout the study lifecycle.
- Regulatory Compliance: Ensure all programming activities comply with regulatory requirements and guidelines, including GCP, ICH, and FDA standards.
- Documentation: Maintain thorough documentation of programming activities, including program specifications, validation plans, and user guides.
Qualifications:
- Education: Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
- Experience: Minimum of 5 years of experience in statistical programming, with direct experience in diabetes research or clinical trials.
- Skills: Proficiency in SAS programming, strong analytical and problem-solving skills, excellent written and verbal communication skills.
- Knowledge: In-depth knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
