Sr. Statistical Programmer

Katalyst CRO; Cincinnati (OH); On-site; USD 85,000 - 105,000; Full time

Job summary

A clinical research organization in Cincinnati is seeking an experienced Statistical Programmer. This role involves ensuring quality programming activities, generating datasets, and maintaining documentation. Candidates must have a Bachelor's degree in a related field and at least 6 years of experience in the biotech or pharmaceutical industry. Ideal candidates will demonstrate extensive knowledge in SAS, including SAS Macros, and must have experience overseeing contractors. This position offers an opportunity to train and mentor team members in a dynamic environment.

Qualifications

• 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.

Responsibilities

• Ensure departmental or functional training plans in place.
• Perform vendor qualifications regarding statistical programming functions.
• Generate, validate, and/or review SDTM domains and ADaM datasets.
• Maintain complete and auditable documentation of all programming activities.
• Train and mentor new members and programmers.

Skills

Extensive knowledge of SAS Macros

Knowledge of Base SAS

Knowledge of SAS/STAT

Knowledge of SAS/Graph

Knowledge of SAS/SQL

Knowledge of SAS/ODS

Experience with R

Experience with Python

Experience with Spotfire

Education

Bachelor's degree in Statistics, Mathematics, Computer Science or a related field

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
• 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.