Responsibilities:
Requirements:
- Implement CSDIC standards and guidelines for data management and analysis in clinical trials.
- Transform and map raw clinical trial data to SDTM and ADaM datasets.
- Collaborate with clinical teams to ensure data quality and accuracy, with a focus on oncology products.
- Generate analysis-ready datasets for statistical analysis and reporting.
- Conduct statistical analyses to evaluate the safety and efficacy of oncology therapies.
- Prepare tables, listings, and figures (TLFs) for clinical study reports.
- Ensure compliance with regulatory requirements for data submissions.
- Contribute to the development of data quality control processes.
- Participate in data visualization and data cleaning tasks as needed.
- Stay updated with industry standards, best practices, and emerging trends in SAS programming for clinical trials.
Requirements:
- Bachelor's degree in a related field from a United States college or university (master's degree preferred).
- 5+ years of experience as a SAS Statistical Programmer in the pharmaceutical, biotechnology, or clinical research industry.
- Deep understanding of CSDIC standards, SDTM, and ADaM.
- Experience working on oncology products and clinical trials.
- Proficiency in SAS programming, including data transformation and statistical analysis.
- Familiarity with regulatory submissions and compliance.
- Strong problem-solving and analytical skills.
- Excellent communication and teamwork abilities.
- Detail-oriented with a commitment to data quality and accuracy.