Senior Statistical Programmer - Lead SDTM/ADaM

Katalyst CRO; Baltimore (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in Baltimore seeks a Senior Statistical Programmer to lead programming activities and deliver analysis datasets, listings, tables and graphs for regulatory submissions. You will design, validate, update and document SAS programs and collaborate with cross-functional teams to ensure data integrity for clinical studies.

Requirements include 6+ years in bio-pharma statistical programming, strong SAS/Base/Macro/STAT/Graph/SQL, and CDISC SDTM/ADaM/CDASH expertise.

Qualifications

• Bachelor's degree in Biostatistics, Mathematics, Statistics, Computer Science, or related field.
• Minimum 6 years' experience in bio-pharma statistical programming.
• Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures.
• Strong expertise in CDISC including SDTM, ADaM, and CDASH.
• Extensive experience in SAS macro functions and dynamic code generations.
• Experience in regulatory submissions (e.g., NDAs and DSURs).

Responsibilities

• Independently develop, validate, document and troubleshoot SAS programs for the preparation of periodic internal reports, regulatory submissions, and ad hoc analyses.
• Create and maintain analysis and submission datasets (ADaM, SDTM) in compliance with CDISC standards and regulatory guidance.
• Design, develop, validate, update, and document SAS programs to generate analysis datasets, data listings, tables, and graphs of high quality in a timely manner.
• Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies.
• Communicate with team members about statistical programming related to trial timelines, data quality, and results interpretation.
• Develop software tools, SAS macros and utilities to automate programming activities and improve programming efficiency and quality.
• Create SAS macros or other tools to enhance the efficient delivery of statistical services, providing associated documentation and staff training as needed.
• Program quality checks for clinical study raw data and report findings.
• Review or author SDTM and ADaM specifications and datasets.
• Manage CROs, including reviewing or validating statistical deliverables of vendors.
• Provides input in the design and development of case report forms.
• Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.

Skills

SAS programming

CDISC SDTM/ADaM/CDASH

SAS/Macro

SAS/STAT

SAS/Base/SAS/Graph/SAS/SQL

Regulatory submissions

SAS macros

Education

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

Tools

SAS

CDISC standards (SDTM/ADaM/CDASH)

Job description

Katalyst CRO in Baltimore seeks a Senior Statistical Programmer to lead programming activities and deliver analysis datasets, listings, tables and graphs for regulatory submissions. You will design, validate, update and document SAS programs and collaborate with cross-functional teams to ensure data integrity for clinical studies.

Requirements include 6+ years in bio-pharma statistical programming, strong SAS/Base/Macro/STAT/Graph/SQL, and CDISC SDTM/ADaM/CDASH expertise.