SDTM & Clinical SAS Lead | Python Pro (Onsite PA)

Noblesoft Technologies Inc.; North Wales (Montgomery County); On-site; USD 120,000 - 160,000; Full time

Job summary

Noblesoft Technologies Inc. is seeking a Technical Lead with SDTM, Clinical SAS, and Python expertise to lead data programming for SDTM/ADaM submissions.

You will act as the primary programming contact for biostatisticians and study teams, review code for accuracy, and ensure CDISC compliance. The role requires 6–8 years in the clinical domain, deep SDTM knowledge, and the ability to create advanced SAS macros and templates to streamline data processing.

Qualifications

• 6–8 years of experience in the clinical domain.
• Strong knowledge of SDTM.
• Create advanced SAS macros, templates, and utilities for efficient data processing.
• Act as the primary programming point of contact for biostatisticians and study teams.
• Perform peer review of code and documentation for accuracy and traceability.
• Review CRF annotations and data specifications.
• Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines.

Responsibilities

• Extensive programming experience in a clinical trial environment (CRO/Pharma).
• Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
• In-depth knowledge of CDISC standards and regulatory submission requirements.

Skills

SDTM

Clinical SAS

Python

SAS macros

CDISC standards

FDA/ICH guidelines

SAS/BASE

SAS/STAT

SAS/MACRO

Tools

SAS/BASE

SAS/STAT

SAS/MACRO

Job description

Noblesoft Technologies Inc. is seeking a Technical Lead with SDTM, Clinical SAS, and Python expertise to lead data programming for SDTM/ADaM submissions.

You will act as the primary programming contact for biostatisticians and study teams, review code for accuracy, and ensure CDISC compliance. The role requires 6–8 years in the clinical domain, deep SDTM knowledge, and the ability to create advanced SAS macros and templates to streamline data processing.