Job Details
Sr. Statistical Analyst
2025-10-21 Katalyst Healthcares & Life Sciences Chula Vista,CA
Description:
Job Description:
Responsibilities:
Requirements:
- The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products.
- The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity.
- The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.
Responsibilities:
- Leads the statistical programming activities for projects with lower complexity.
- Leads the statistical programming activities for studies.
- Develop SAS programs for the creation of ADaM data sets following
CDISC standards. - Develop SAS programs for the creation of Tables, Listings and Figures.
- Validation of ADaM data sets, Tables, Listings and Figures.
- Create specifications for the structure of ADaM data sets for individual studies and integrated data.
- Create documentation for regulatory filings including reviewers guides and data definition documents
- Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
- Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.
Requirements:
- MS in Statistics, Computer Science or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
- In-depth understanding of SAS programming concepts and techniques related to drug development.
- Fundamental understanding of CDISC Standards.
- Fundamental understanding of the drug development process, including experience with regulatory filings.
- Ability to communicate clearly both oral and written.
- Ability to accurately estimate effort required for study related programming activities.