Senior Statistical Programmer

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 is seeking an experienced Senior Statistical Programmer with a strong background in clinical trial programming and regulatory submissions. The ideal candidate will have 8-10 years of statistical programming experience within the pharmaceutical or CRO industry, including hands-on experience supporting FDA submissions and developing Define-XML. They must already live in the San Francisco Bay area.

This individual will play a key role in clinical trial programming activities, ensuring high-quality deliverables, CDISC compliance, and successful regulatory submissions.

Key Responsibilities

• Lead and independently perform statistical programming activities for Phase I-III clinical trials.
• Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards.
• Generate and validate tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions.
• Support NDA/BLA submissions, including preparation and validation of submission-ready datasets and associated documentation.
• Develop, maintain, and validate Define-XML files for regulatory submissions.
• Support FDA regulatory responses, including programming analyses and addressing data-related inquiries.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and other cross-functional teams.
• Review protocols, statistical analysis plans (SAPs), TLF shells, and dataset specifications.
• Perform quality control and validation of programming deliverables to ensure accuracy, consistency, and regulatory compliance.
• Provide technical guidance and programming support to team members as needed.

Required Qualifications

• 8-10 years of statistical programming experience in a pharmaceutical company or CRO, ideally no more than 10 years of industry experience.
• Direct, hands-on experience supporting regulatory submissions (NDA/BLA).
• Demonstrated experience creating, maintaining, and validating Define-XML for regulatory submissions.
• Advanced proficiency in SAS programming, including Base SAS, SAS/STAT, and SAS Macro language.
• Strong working knowledge of CDISC standards, including SDTM and ADaM.
• Extensive experience developing and validating clinical trial datasets, tables, listings, and figures.
• Strong understanding of clinical trial processes, statistical programming standards, and regulatory requirements.
• Ability to work independently, manage multiple deliverables, and meet project timelines.
• Excellent communication, collaboration, and problem-solving skills.

Preferred Qualifications

• Experience serving as a Lead Statistical Programmer on clinical studies.
• Experience supporting integrated summaries of safety and efficacy (ISS/ISE).
• Experience with FDA submission packages, reviewer guides, and regulatory responses.
• Experience using Pinnacle 21 for CDISC compliance validation.
• Experience across multiple therapeutic areas, including Oncology, Hematology, Immunology, or CNS.
• Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related discipline.

About NJS Associates

NJS Associates specializes in providing high-quality biometrics and statistical programming solutions to the pharmaceutical and biotechnology industries. Our team supports clinical development programs through expertise in statistical programming, biostatistics, data management, and regulatory submissions.