POSITION DUTIES:

● Draft and refine comprehensive Statistical Analysis Plans (SAP) and corresponding mock shells for tables, listings, and figures.

● Build, validate, and maintain SDTM and ADaM datasets in alignment with CDISC standards, covering domains such as DM, AE, LB, TU, TR, RS, VS, SV, ADSL, ADEG, ADRS, ADTTE and ADLB.

● Prepare and quality-control ADaM specifications, incorporating updates driven by SAP changes and TLF mock-up requirements.

● Collaborate closely with internal statistical programming teams to produce TLFs for efficacy, safety, demographic summaries, disposition events, baseline analyses, laboratory evaluations, and time-to-event endpoints.

● Develop macros and automated programs to support data review, domain listings, ad hoc analyses, and comparison of multiple raw dataset transfers to flag discrepancies for statisticians, clinical teams, and data managers.

● Conduct survival analyses using SAS procedures such as PROC LIFETEST and generate customized Kaplan–Meier plots via PROC TEMPLATE and SGRENDER, reporting survival estimates, medians, and significance levels through PROC REPORT.

● Lead safety-related exploratory research using integrated study data, preparing publication-ready outputs—including tables, figures and listings—related to oncology indicators.

● Create re-usable SAS macros to streamline generation of listings and tables and improve overall programming efficiency.

● Perform exploratory statistical analyses upon request, including subgroup assessments, variance exploration, and preliminary model investigations.

● Support integration of safety datasets (ISS), derive additional ADaM variables such as SMQ flags, special-interest event indicators, and DSUR-related safety variables.

● Review annotated CRFs, SDTM and ADaM mapping documents, programming specifications, and other study-level materials to ensure end-to-end consistency.

● Participate in internal and client-facing meetings to align project deliverables and study timelines. Join regular discussions with CRO teams to review validation findings and resolve programming or data-related issues.

● Prepare submission-related materials such as reviewer guides, data definition files, and conformance reports using tools like Pinnacle 21.

Salary $ 82000.00 plus employee standard benefits.

LOCATION OF EMPLOYMENT （Street Address): 30B Vreeland Road, Suite 304, Florham Park, NJ 07932.

POSITION REQUIREMENTS:

Master’s degree in Statistics/Computer Science/Computer Engineering or related field and SAS Certificate Programmer.

Ability to work with CDISC standards, including SDTM and ADaM dataset development.

Advanced SAS programming skills include data manipulation, derivation, validation, and macro development. Proficiency with statistical methods and SAS procedures such as PROC

FREQ, MEANS, MIXED, SQL, PHREG, and LIFETEST.

Ability to use R for data analysis and visualization.

Familiarity with statistical procedures such as descriptive statistics, linear models, mixed models, and survival analysis.

Skill in reviewing CRFs, dataset specifications, SAP documents, and programming guides.

Ability to generate regulatory-compliant deliverables such as reviewer guides, define.xml files, and data conformance reports.

Knowledge of clinical trial processes, data structures, and statistical reporting conventions.

Pay: $82,000.00 per year

Work Location: In person