Sr. Statistical Programmer – Level 2

Clymb Clinical LLC; Burlington; On-site; CAD 90,000 - 120,000; Full time

Job summary

Clymb Clinical LLC, a leader in clinical data analysis, is expanding its team and seeking a full-time Sr. Statistical Programmer - Level 2. The role requires strong expertise in SAS programming, CDISC standards, and project management skills to support clinical studies and regulatory submissions. A Master's degree is preferred, along with significant programming experience and the ability to work autonomously.

Qualifications

• Master’s degree or equivalent with minimum 5 years of SAS experience.
• 3+ years of hands-on CDISC implementation experience.
• Strong understanding of FDA regulatory guidance around Study Data.

Responsibilities

• Conduct reviews of study documents like Protocol and SAP.
• Create statistical programs in SAS and/or R for CDISC datasets.
• Ensure validation and quality control for programs and datasets.

Skills

SAS programming

CDISC implementation

R programming

Quality Control

Statistical analysis

Leadership

Education

Master's degree

Bachelor's degree

Tools

SAS

CDISC

Job description

Our group is growing rapidly, and we are currently seeking a full-time, Sr. Statistical Programmer - Level 2 to join our team.

The Sr. Statistical Programmer - Level 2 will develop and validate technical programming specifications and programs, and generate SDTM and ADaM datasets, tables, figures, and listings. The incumbent should be able to work independently implementing and executing the programming and project standard to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc / post hoc analysis.

This position is direct hire, no third parties please.

Responsibilities

• Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
• Create and assess statistical programs in SAS and / or R to produce CDISC-compliant SDTM and ADaM datasets.
• Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
• Development and review of CDISC SDTM and ADaM mapping specifications.
• Produce and review Tables, Figures, and Listings (TFLs) in accordance with the SAP.
• Review datasets for any pending compliance issues and meticulously document identified issues.
• Generation and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.
• Generation of utility macros and efficient code writing to streamline programming processes.
• Communicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.
• Adherence to Clymb and / or client’s Policies and Procedures.

Requirements :

• Master’s degree or equivalent, along with relevant formal academic / vocational qualifications and a minimum of 5 years of SAS programming experience. Alternatively, a Bachelor’s degree with 7+ years of SAS programming experience.
• A minimum of 3 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS / MACRO, SAS / GRAPH; systems and database expertise.
• Previous involvement as a production or QC programmer at both product and study levels.
• Strong organizational, interpersonal, leadership, and communication skills.
• Ability to autonomously manage multiple tasks and projects.
• In-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
• A minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.