Sr. Manager Statistical Programmer

5 days ago


Boston, MA, United States Katalyst Healthcares and Life Sciences Full time
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.
  • bility to communicate clearly both oral and written.
  • bility to effectively represent the Statistical Programming Organization in cross functional teams.
  • bility to accurately estimate effort required for project related programming activities.


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