Sr. Statistical Programmer

Katalyst CRO; Cincinnati (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a skilled Statistical Programmer in Cincinnati, OH to lead programming for clinical trials and ensure regulatory-grade deliverables.

You will generate SDTM/ADaM datasets, validate tables and listings, and maintain rigorous documentation while mentoring junior staff and coordinating with CRO contractors.

Qualifications

• Bachelor's degree required in statistics, math, CS or related field.
• Minimum of 6 years biotech/pharma/CRO experience as a statistical programmer.
• Experience overseeing statistical programming contractors.
• eCTD NDA submission experience is required.

Responsibilities

• Ensure training plans are in place and appropriate.
• Manage CRO programming issues and on-time deliverables within budget.
• Generate and review SDTM domains and ADaM datasets and specs.
• Create tables, figures and listings for regulatory submissions/publications.
• Quality control SAS programs and study documents.
• Maintain auditable documentation of programming activities.
• Manage datasets across SAS programs and studies for consistency.
• Support supplemental analyses for pharmacovigilance or ad-hoc requests.
• Develop and maintain departmental SAS utilities and validation procedures.
• Review CRFs, edit checks, and table/listing/figure mock-ups.
• Assist in validation of SAS per 21 CFR Part 11.
• Train and mentor new programmers; supervise contract programmers.

Skills

Statistical programming

Vendor management

Training & mentoring

CRO industry experience

Education

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

Tools

Base SAS

SAS/STAT

SAS/Graph

SAS/SQL

SAS/ODS

SAS Macros

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.