Clinical SAS Programmer

Katalyst CRO; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO seeks an experienced Statistical Programmer to design and code SAS programs for clinical projects, delivering regulatory-compliant SDTM/ADaM datasets, TFLs, and analyses.

You will contribute to CRF and database design, perform robust QC, and develop reusable macros to boost efficiency across a multidisciplinary team in a fast-paced environment.

Qualifications

• MS in Statistics, Computer Science, or related field with at least 3 years (or BS with at least 5 years).
• Experience providing statistical programming support to early and late phase clinical trials.
• Excellent SAS programming and statistical reporting skills.
• Knowledge of CDISC SDTM and ADaM standards and FDA submissions.
• Familiarity with FDA and ICH regulations and guidelines.
• Strong problem-solving, communication, and documentation skills.
• Ability to work in a multidisciplinary team.

Responsibilities

• Design and code SAS programs for clinical projects using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
• Produce CDISC SDTM and ADaM datasets that are regulatory compliant.
• Create and validate tables, figures, and listings (TFLs) meeting study objectives and requirements.
• Contribute to design of case report forms and clinical databases.
• Perform quality checks of SAS code and outputs for SDTM/ADaM datasets and TFLs.
• Develop global tools (macros, GUI apps) to increase efficiency.
• Review eCRF, SDTM and ADaM datasets specifications and provide programming support for adhoc analyses.
• Collaborate across Biostatistics, Data Management, Medical Writing, and other functions.

Skills

SAS programming

SDTM/ADaM

Statistical reporting

Regulatory standards

Problem-solving

Communication

Team collaboration

Education

MS in Statistics, Computer Science, or related field

BS in Statistics, Computer Science, or related field

Tools

SAS/STAT

SAS Macros

Job description

Responsibilities

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
• Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets.
• Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
• Provides input in the design and development of case report forms and clinical databases.
• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
• Programs quality checks for clinical study raw data and report the findings to Data Management
• Provides input in the design and development of case report forms and clinical study databases.
• Reviews or author eCRF, SDTM and ADaM datasets specifications for datasets programming
• Provides programming support for adhoc analysis.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)

Requirements

• MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
• Experience in providing statistical programming support to early and late phase clinical trials.
• Excellent skills in SAS programming and statistical reporting.
• Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
• Familiarity with FDA and ICH regulations and guidelines.
• Excellent problem-solving skills.
• Good written and verbal communication skills and organizational and documentation skills.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.