Katalyst Healthcares and Life Sciences
Sr. Manager Statistical Programmer
Katalyst Healthcares and Life Sciences - Boston, Massachusetts, us, 02298
Work at Katalyst Healthcares and Life Sciences
Overview
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Overview
Responsibilities:
The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Leads the statistical programming activities for one or more compounds/indications or a therapeutic area. Manages a team of statistical programmers and the resource planning for their assigned projects. Ensures timely deliverables, that all quality processes are followed and consistency within the projects. Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards. Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures. Ensures consistency of ADaM data sets for individual studies and integrated data. Creates documentation for regulatory filings including reviewers guides and data definition documents. Leads the development of standard SAS Macros and the development of standard operating procedures. Manages, mentors and creates career development plans for assigned staff. Participates in the recruitment and selection of new staff. Requirements:
MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. Minimum of 2 years' experience leading a team of statistical programmers. In-depth understanding of SAS programming concepts and techniques related to drug development. In-depth understanding of CDISC Standards. In-depth understanding of the drug development process, including experience with regulatory filings. Ability to communicate clearly both oral and written. Ability to effectively represent the Statistical Programming Organization in cross functional teams. Ability to accurately estimate effort required for project related programming activities.
The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Leads the statistical programming activities for one or more compounds/indications or a therapeutic area. Manages a team of statistical programmers and the resource planning for their assigned projects. Ensures timely deliverables, that all quality processes are followed and consistency within the projects. Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards. Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures. Ensures consistency of ADaM data sets for individual studies and integrated data. Creates documentation for regulatory filings including reviewers guides and data definition documents. Leads the development of standard SAS Macros and the development of standard operating procedures. Manages, mentors and creates career development plans for assigned staff. Participates in the recruitment and selection of new staff. Requirements:
MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. Minimum of 2 years' experience leading a team of statistical programmers. In-depth understanding of SAS programming concepts and techniques related to drug development. In-depth understanding of CDISC Standards. In-depth understanding of the drug development process, including experience with regulatory filings. Ability to communicate clearly both oral and written. Ability to effectively represent the Statistical Programming Organization in cross functional teams. Ability to accurately estimate effort required for project related programming activities.