Job Description

• 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.
• 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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