Senior Statistical Programmer

6 days ago

Santa Clara, CA, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Ensure departmental or functional training plans in place and appropriate.
  • Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget.
  • Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications.
  • Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
  • Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Manage datasets and output across SAS programs, studies, and indications to ensure consistency.
  • Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests.
  • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Develop and/or maintain departmental procedures and standards.
  • Review CRFs, edit check specifications, and table, figure, and listing mock-ups.
  • Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documents.
  • ssist in validation of SAS per 21 CFR Part 11.
  • Train and mentor new members and programmers; supervise contract programmers, as needed.
Requirements:
  • Bachelor's degree in Statistics, Mathematics, Computer Science or a related field required.
  • Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer.
  • Prior experience overseeing statistical programming contractors required.
  • Compound oversight experience highly preferred.
  • Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
  • ECTD NDA submission experience is a must.

  • Lead Statistical Programmer

    6 days ago

    Santa Clara, CA, United States Redbock - an NES Fircroft company Full time

    Overview: Join our innovative team as a Lead Statistical Programmer, where you'll be crucial in steering our statistical programming e-submission efforts. We are looking for a talented individual with recent experience in leading submissions to help us drive success in our projects. Qualifications: Over 12 years of statistical programming experience in the...

  • Senior Software Engineer

    8 hours ago

    Santa Clara, CA, United States Microsoft Corporation Full time

    Overview Microsoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft's expanding Cloud Infrastructure and responsible for powering Microsoft's "Intelligent Cloud" mission. SCHIE delivers the core infrastructure and foundational technologies for Microsoft's over 200 online businesses including Bing, MSN, Office 365,...

  • Senior Software Engineer

    2 days ago

    Santa Clara, CA, United States Microsoft Corporation Full time

    Overview Microsoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft's expanding Cloud Infrastructure and responsible for powering Microsoft's "Intelligent Cloud" mission. SCHIE delivers the core infrastructure and foundational technologies for Microsoft's over 200 online businesses including Bing, MSN, Office 365,...

  • Senior Software Engineer

    1 week ago

    Santa Clara, CA, United States Microsoft Corporation Full time

    Overview Microsoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft's expanding Cloud Infrastructure and responsible for powering Microsoft's "Intelligent Cloud" mission. SCHIE delivers the core infrastructure and foundational technologies for Microsoft's over 200 online businesses including Bing, MSN, Office 365,...

  • Senior Software Engineer

    1 week ago

    Santa Clara, CA, United States Microsoft Corporation Full time

    Overview Microsoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft's expanding Cloud Infrastructure and responsible for powering Microsoft's "Intelligent Cloud" mission. SCHIE delivers the core infrastructure and foundational technologies for Microsoft's over 200 online businesses including Bing, MSN, Office 365,...

  • Senior Software Engineer

    4 days ago

    Santa Clara, CA, United States Microsoft Corporation Full time

    Overview Microsoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft's expanding Cloud Infrastructure and responsible for powering Microsoft's "Intelligent Cloud" mission. SCHIE delivers the core infrastructure and foundational technologies for Microsoft's over 200 online businesses including Bing, MSN, Office 365,...

  • Senior PL/SQL Developer

    9 hours ago

    Santa Ana, CA, United States Kaav Inc. Full time

    Duties and Responsibilities (Please provide a detailed job description): Contractor shall perform duties as directed by Court and on a Time and Material basis. Duties include, but are not limited to, the following: o Programming: Use PowerBuilder and Oracle PL/SQL skills to enhance Vision application functionalities, generate reports, develop backend...

  • Senior PL/SQL Developer

    6 days ago

    Santa Ana, CA, United States Kaav Inc. Full time

    Duties and Responsibilities (Please provide a detailed job description): Contractor shall perform duties as directed by Court and on a Time and Material basis. Duties include, but are not limited to, the following: o Programming: Use PowerBuilder and Oracle PL/SQL skills to enhance Vision application functionalities, generate reports, develop backend...

  • Senior PL/SQL Developer

    1 week ago

    Santa Ana, CA, United States Kaav Inc. Full time

    Duties and Responsibilities (Please provide a detailed job description): Contractor shall perform duties as directed by Court and on a Time and Material basis. Duties include, but are not limited to, the following: o Programming: Use PowerBuilder and Oracle PL/SQL skills to enhance Vision application functionalities, generate reports, develop backend...

  • Senior PL/SQL Developer

    1 week ago

    Santa Ana, CA, United States Kaav Inc. Full time

    Duties and Responsibilities (Please provide a detailed job description): Contractor shall perform duties as directed by Court and on a Time and Material basis. Duties include, but are not limited to, the following: o Programming: Use PowerBuilder and Oracle PL/SQL skills to enhance Vision application functionalities, generate reports, develop backend...