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Urgent! Principal Statistical Programmer Job Opening In Philadelphia Pennsylvania – Now Hiring Katalyst Healthcares & Life Sciences

Principal Statistical Programmer



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 (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.


  • Assist in validation of SAS per 21 CFR Part 11.



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.





Required Skill Profession

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