Senior Statistical Programmer

Katalyst Healthcares and Life Sciences

Boulder, CO

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.

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Vacancy posted 3 days ago

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