Senior Statistical Programmer - CDISC & NDA Submissions

NJS Associates Company; San Francisco (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

NJS Associates seeks an experienced Senior Statistical Programmer in the San Francisco Bay Area. The role focuses on leading statistical programming for Phase I-III trials, developing SDTM/ADaM datasets, and delivering TLFs for regulatory submissions.

Candidates should have 8-10 years of industry experience and hands-on NDA/BLA submission work. Proficiency in SAS (Base, STAT, Macros) and Define-XML is required, with strong CDISC knowledge.

Qualifications

• 8-10 years of statistical programming experience in pharma/CRO.
• Hands-on experience supporting regulatory submissions (NDA/BLA).
• Experience creating, maintaining, and validating Define-XML for regulatory submissions.
• Strong proficiency in SAS programming (Base SAS, SAS/STAT, SAS Macro language).
• Knowledge of CDISC standards (SDTM, ADaM) and developing clinical trial datasets and TLFs.
• Ability to work independently, manage multiple deliverables, and meet timelines.
• Excellent communication and collaboration skills.

Responsibilities

• Lead and independently perform statistical programming for Phase I-III trials.
• Develop, validate, and maintain SDTM and ADaM datasets per CDISC standards.
• Generate and validate tables, listings, and figures for reports and regulatory submissions.
• Support NDA/BLA submissions, including submission-ready datasets and documentation.
• Develop, maintain, and validate Define-XML files for regulatory submissions.
• Support FDA regulatory responses and data-related inquiries.
• Collaborate with Biostatistics, Data Management, and Clinical Operations.
• Review protocols, SAPs, and dataset specifications.
• QC and validate programming deliverables for accuracy and regulatory compliance.
• Provide technical guidance and programming support to team members.

Skills

Statistical programming

SAS programming

CDISC SDTM

ADaM

Define-XML

FDA submissions

Collaborative work

SAS macros

Education

Bachelor's or Master's in Statistics/Biostatistics

Tools

Pinnacle 21

Job description

NJS Associates seeks an experienced Senior Statistical Programmer in the San Francisco Bay Area. The role focuses on leading statistical programming for Phase I-III trials, developing SDTM/ADaM datasets, and delivering TLFs for regulatory submissions.

Candidates should have 8-10 years of industry experience and hands-on NDA/BLA submission work. Proficiency in SAS (Base, STAT, Macros) and Define-XML is required, with strong CDISC knowledge.