Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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
- 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.