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Senior Statistical Programmer Job Opening In Worcester – Now Hiring Katalyst HealthCares & Life Sciences


Job description


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 (, 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 , , , and reviewer's guide documents.

  • Assist in validation of SAS per CFR Part .

  • 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 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, CFR Part , and FDA guidelines.

  • eCTD NDA submission experience is a must.


  • Required Skill Profession

    Mathematical Science Occupations


    • Job Details

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    184698
    74 Jobs in Worcester
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