cGxPServe

Principal Statistical Programmer

6 days ago

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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 delivery within budget on time.
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.