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Senior Statistical Programmer Analyst
Location
United States
Posted
97 days ago
Salary
0
Job Description
Senior Statistical Programmer Analyst
Jobgether
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role provides a unique opportunity to contribute to early-stage immuno-oncology clinical programs by leading the development and execution of statistical programming and analyses. You will ensure submission-ready study data packages, maintain compliance with CDISC standards and FDA guidance, and support internal and external stakeholders across biostatistics, clinical operations, and regulatory teams. The position offers hands-on technical work with SAS, R, Python, and Unix, while influencing program quality, efficiency, and innovation. You will operate in a collaborative, fast-paced environment, managing complex datasets, generating TFLs, and creating SDTM/ADaM outputs for regulatory submissions and publications. This contract role allows for remote work within the United States, providing both flexibility and the chance to make a tangible impact on the clinical development pipeline. - Develop specifications and execute programs for internal data reviews, publications, exploratory, post-hoc, and regulatory analyses - Ensure study data packages comply with CDISC standards (SDTM, ADaM) and health authority reporting requirements - Collaborate with clinical data management to review case report forms, database, and data transfer specifications - Create and review SDTM/ADaM mapping specifications, reviewer’s guides, and define.xml files - Generate or validate TFLs to support statistical analyses for clinical studies, regulatory submissions, and publications - Prioritize analytical deliverables strategically, including study-level or integrated analyses for safety signal detection or business needs - Manage timely and quality delivery of CRO-generated analysis results Qualifications - Bachelor’s or Master’s degree in Statistics, Mathematics, Epidemiology, Computer Science, Bioinformatics, or related field - 8+ years of programming experience in biotechnology or pharmaceutical clinical trial environments - Expert-level skills in SAS programming, with strong experience in R, Python, Unix scripts, and macro development - Solid understanding of CDISC standards (SDTM, ADaM), controlled terminology, and regulatory submission requirements - Ability to translate complex clinical and statistical problems into clear, functional code and tools - Experience with software development and testing, project management, and programming best practices - Knowledge of ICH-GCP, 21 CFR Part 11, and relevant clinical R&D concepts - Excellent written and verbal communication skills, with the ability to manage priorities and collaborate effectively Benefits - Competitive contract compensation - Flexible remote work within the United States - Exposure to cutting-edge immuno-oncology research and clinical development - Opportunity to work collaboratively with a growing Biometrics team - Professional growth through experience with regulatory submissions and complex statistical programming
Job Requirements
- Bachelor’s or Master’s degree in Statistics, Mathematics, Epidemiology, Computer Science, Bioinformatics, or related field
- 8+ years of programming experience in biotechnology or pharmaceutical clinical trial environments
- Expert-level skills in SAS programming, with strong experience in R, Python, Unix scripts, and macro development
- Solid understanding of CDISC standards (SDTM, ADaM), controlled terminology, and regulatory submission requirements
- Ability to translate complex clinical and statistical problems into clear, functional code and tools
- Experience with software development and testing, project management, and programming best practices
- Knowledge of ICH-GCP, 21 CFR Part 11, and relevant clinical R&D concepts
- Excellent written and verbal communication skills, with the ability to manage priorities and collaborate effectively
Benefits
- Competitive contract compensation
- Flexible remote work within the United States
- Exposure to cutting-edge immuno-oncology research and clinical development
- Opportunity to work collaboratively with a growing Biometrics team
- Professional growth through experience with regulatory submissions and complex statistical programming
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VeevaHeadquartered in Pleasanton, California, Veeva is a leading provider of cloud-based software and services for the life sciences industry. As an employer, Veeva
• Translate customer needs into development initiatives which you will then drive and coordinate • Work cross functionally with both customer facing teams as well as PMs and development teams • Ensure that data gets built with the highest quality and then presented in the right way through the UI • Work with smart and dedicated colleagues will ensure you are constantly challenged in this role • Drive and coordinate product development initiatives with Data and Software PMs • Develop requirements and feature specifications • Support customer-facing teams around data and product questions • Suggest improvements and new features around our data based on customer needs • Monitor data quality and identify new, relevant ways of measuring this • Coordinate and communicate across multiple teams and functions
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VeevaHeadquartered in Pleasanton, California, Veeva is a leading provider of cloud-based software and services for the life sciences industry. As an employer, Veeva
• Translate customer needs into development initiatives which you will then drive and coordinate • Work cross functionally with both customer facing teams as well as PMs and development teams • Ensure that data gets built with the highest quality and then presented in the right way through the UI • Work with smart and dedicated colleagues will ensure you are constantly challenged in this role • Drive and coordinate product development initiatives with Data and Software PMs • Develop requirements and feature specifications • Support customer-facing teams around data and product questions • Suggest improvements and new features around our data based on customer needs • Monitor data quality and identify new, relevant ways of measuring this • Coordinate and communicate across multiple teams and functions
