Statistical Programmer

Lancesoft; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in clinical research is seeking an experienced Statistical Programmer. The role involves transforming clinical trial data into SDTM and ADaM datasets, ensuring compliance with standards. Ideal candidates will have extensive experience with SAS and a solid understanding of the drug development lifecycle.

Qualifications

• 6+ years of experience in clinical trial programming using SAS.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Experience with clinical trial data and drug development lifecycle.

Responsibilities

• Convert raw clinical trial data into SDTM-compliant datasets.
• Derive ADaM datasets from SDTM datasets based on statistical analysis plans.
• Validate datasets through double programming and automated tools.

Skills

SAS Base

SAS Macro

SQL

CDISC SDTM

CDISC ADaM

Education

Bachelor's or Master's degree in Life Sciences

Tools

Pinnacle 21

Job description

Job Summary:

We are seeking a detail-oriented and experienced Statistical Programmer with strong expertise in SDTM and ADaM programming. The ideal candidate will be responsible for transforming raw clinical trial data into SDTM datasets and subsequently into analysis-ready ADaM datasets. This role requires a deep understanding of clinical trial data standards, regulatory requirements, and advanced data manipulation techniques using SAS.

Key Responsibilities:

SDTM Programming:

• Convert raw clinical trial data into SDTM-compliant datasets.
• Develop SDTM specifications and mapping documents.
• Perform gap analysis and resolve data inconsistencies or complex mappings.
• Ensure compliance with CDISC, FDA, and other regulatory standards using tools like Pinnacle 21.
• Conduct validation and quality checks on SDTM datasets.

ADaM Programming:

• Derive ADaM datasets from SDTM datasets based on statistical analysis plans (SAPs).
• Develop detailed ADaM specifications and define derivation logic.
• Implement accurate programming of time-to-event, longitudinal, and derived analysis variables.
• Perform QC and peer reviews to ensure dataset integrity and consistency with SDTM sources.

General Programming and Validation:

• Validate datasets through double programming and automated tools.
• Handle missing data using imputation techniques or sensitivity analysis as appropriate.
• Collaborate with statisticians, data managers, and other stakeholders to ensure accurate data delivery.
• Document programming and validation steps for audit readiness and regulatory submissions.

Required Qualifications:

• Bachelors or master’s degree in Life Sciences, or a related field.
• 6+ years of experience in clinical trial programming using SAS.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Proficiency in SAS Base, Macro, and SQL.
• Experience with clinical trial data and the drug development lifecycle.
• Familiarity with Pinnacle 21 and other CDISC validation tools.

Preferred Qualifications:

• Knowledge with R, Python, or other programming languages for data analysis.
• Exposure to regulatory submission processes (e.g., FDA, PMDA).
• Knowledge of SDTM and ADaM IG (Implementation Guides).
• Familiarity with data standards compliance, audit procedures, and documentation practices.