Senior Statistical Programmer — SDTM/ADaM, SAS Expert

i-Pharm Consulting; New Jersey; On-site; USD 120,000 - 160,000; Full time

Job summary

i-Pharm Consulting seeks an experienced Senior Statistical Programmer to support clinical studies and regulatory submissions within a fast-paced biotech environment. You will develop and validate SDTM/ADaM datasets, produce TFLs, and contribute to SAPs while collaborating with cross-functional teams.

The role requires strong SAS programming skills, hands-on CDISC experience, and a track record of delivering high-quality outputs for regulatory submissions.

Qualifications

• Bachelor's degree in Mathematics, Statistics, Computer Science or a related field.
• Proven experience with SAS programming in clinical studies.
• Hands-on experience with CDISC standards (SDTM/ADaM) and regulatory submissions.

Responsibilities

• Provide statistical programming support across clinical studies and regulatory submissions.
• Develop, maintain, and validate CDISC-compliant SDTM and ADaM datasets.
• Produce and validate Tables, Figures, and Listings (TFLs) for clinical studies and analyses.
• Create dataset specifications in accordance with SDTM IG, ADaM IG, and SAPs.
• Design, develop, test, and implement programming solutions to meet complex business requirements.
• Develop, maintain, and enhance SAS macros and other programming utilities.
• Perform ad-hoc, exploratory, and validation analyses as required.
• Collaborate with cross-functional teams and study teams to deliver results on time.
• Manage multiple projects with high quality within strict timelines.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Clinical data analysis

Communication skills

Education

Bachelor's degree in Mathematics, Statistics, Computer Science

Tools

Python

VBA

SAS Macros

Job description

i-Pharm Consulting seeks an experienced Senior Statistical Programmer to support clinical studies and regulatory submissions within a fast-paced biotech environment. You will develop and validate SDTM/ADaM datasets, produce TFLs, and contribute to SAPs while collaborating with cross-functional teams.

The role requires strong SAS programming skills, hands-on CDISC experience, and a track record of delivering high-quality outputs for regulatory submissions.