What are the responsibilities and job description for the Senior Statistical Programmer position at Meet Life Sciences?
Overview
Seeking an experienced Senior Statistical Programmer to provide programming support for clinical studies and regulatory submissions. This role will focus on developing and validating CDISC-compliant SDTM and ADaM datasets, creating tables, figures, and listings, and supporting ad-hoc and exploratory analyses. The ideal candidate will have advanced SAS and R programming skills, strong knowledge of CDISC standards, and experience working within a pharmaceutical, biotech, or related environment.
This is a fully onsite position, 5 days per week, at the company’s headquarters in Bridgewater, NJ.
Key Responsibilities
- Provide statistical programming support for clinical studies and regulatory submissions.
- Develop and maintain programs to produce and validate CDISC-compliant SDTM and ADaM datasets.
- Develop programs for ad-hoc and exploratory analyses and other clinical programming needs.
- Develop and maintain programs to produce and validate tables, figures, and listings (TFLs).
- Support publications and other ad-hoc reporting needs.
- Create dataset specifications in accordance with SDTM IG, ADaM IG, and Statistical Analysis Plans (SAPs).
- Develop, maintain, and utilize SAS macros and utility programs.
- Design, develop, test, and implement solutions for complex programming and business requirements.
- Collaborate effectively with biostatistics, clinical, data management, and other cross-functional stakeholders.
- Manage multiple assignments concurrently while meeting project timelines and maintaining a high level of quality.
- Support clinical development and submission-related programming activities as needed.
Required Skills
- Advanced SAS programming skills.
- Strong R programming skills.
- Hands-on experience with CDISC standards, including SDTM and ADaM.
- Experience developing and validating clinical datasets.
- Experience creating and/or validating tables, figures, and listings.
- Strong understanding of SDTM Implementation Guide (SDTM IG), ADaM Implementation Guide (ADaM IG), and SAPs.
- Pharmaceutical, biotechnology, CRO, or related industry experience.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Strong verbal and written communication skills.
- Ability to manage multiple projects and meet deadlines in a project-based environment.
- Prior regulatory submission experience is preferred.
- Experience with VBA, Python, C , or other programming languages is a plus.
Education & Experience
- Bachelor’s degree in Mathematics, Statistics, Computer Science, or a related field.
- Senior-level experience in statistical programming within the pharmaceutical, biotechnology, CRO, or related industry.
- Strong hands-on experience with SAS, R, CDISC, SDTM, and ADaM.
- Prior clinical study programming and/or regulatory submission experience is preferred.