Senior / Principal Analyst, Statistical Programming

SimulStat Incorporated; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

Apr is seeking a Senior/Principal Statistical Programmer for a remote, 12-month renewable contract. The role involves generating SDTM/ADaM specifications and define.xml files, and developing SAS/R programs for datasets, listings, tables, and graphs to support regulatory submissions and publications.

The ideal candidate has a strong CDISC background, familiarity with FDA guidelines, and excellent communication and organizational skills to manage multiple studies across timelines and quality

Qualifications

• BS/BA in computer science, mathematics, statistics, or a related field with 6+ years of biopharma/CRO statistical programming experience, or a Master’s with 4+ years, or a PhD with 2+ years.
• Advanced SAS (Base, Stat, Macro, Graph) required, R a plus.
• Strong command of CDISC standards (SDTM, ADaM) and define.xml.
• Familiarity with 21 CFR Part 11 and FDA electronic submission guidelines.
• Strong communication and organizational skills.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml files.
• Develop and validate SAS and/or R programs for datasets, listings, tables, and graphs. Support clinical study reports, regulatory submissions, publications, and exploratory analyses.
• Manage overlapping deliverables across multiple studies while meeting timelines and quality standards.
• Collaborate with sponsor project leads to keep programs on track.
• Apply FDA regulations, ICH guidelines, and GCP standards to clinical trial data reporting.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

define.xml

FDA 21 CFR Part 11

communication

organizational skills

Education

Bachelor's degree in computer science, mathematics, statistics, or related field

Master’s degree in biostatistics or related field

PhD in a related field

Tools

SAS

R

Job description

Remote, 12-month renewable contract

Statistical Programmer (Senior / Principal)

Responsibilities:

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml files.
• Develop and validate SAS and/or R programs for datasets, listings, tables, and graphs. Support clinical study reports, regulatory submissions, publications, and exploratory analyses.
• Manage overlapping deliverables across multiple studies while meeting timelines and quality standards.
• Collaborate with sponsor project leads to keep programs on track.
• Apply FDA regulations, ICH guidelines, and GCP standards to clinical trial data reporting.

Qualifications:

• BS/BA in computer science, mathematics, statistics, or a related field with 6+ years of biopharma/CRO statistical programming experience, or a Master’s with 4+ years, or a PhD with 2+ years. Advanced SAS (Base, Stat, Macro, Graph) required, R a plus.
• Strong command of CDISC standards (SDTM, ADaM) and define.xml.
• Familiarity with 21 CFR Part 11 and FDA electronic submission guidelines.
• Strong communication and organizational skills.