Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description
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 key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.).
Responsibilities:
Leads the statistical programming activities for projects with lower complexity.
Leads the statistical programming activities for studies.
Create documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros.
Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.
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.
Participates in the development of standard operating procedures.
Requirements:
MS in Statistics, Computer Science or a related field with 5+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 7+ years of relevant experience.
Indepth 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.