On-Board Services is hiring a Remote Senior Statistical Programming ContractorFor immediate consideration please send your resume to Subject Line: Position Title and State you are located Position Details: Title: Sr. Statistical Programming Contractor
Position Type: 3-month contract with additional opportunity contingent upon performance and continued business need
Job Location: Remote
Shift: 1st shift
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance, PTO
Compensation: $2100/HR
Qualifications - 10+ years of hands-on statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Advanced knowledge of GCP/ICH guidelines and FDA regulatory requirements; experience supporting NDA, MAA, and/or BLA submissions preferred.
- Expert-level proficiency in SAS programming, including advanced macro development.
- Strong knowledge and practical experience with CDISC standards, including SDTM, ADaM, Define.xml, and submission-ready datasets.
- Experience supporting clinical and device studies, regulatory submissions, and publication-related programming requests.
- Familiarity with R and/or Python for statistical analysis, automation, or programming solutions is highly desirable.
- Strong project management and organizational skills, with the ability to manage multiple projects, prioritize shifting workloads, and meet tight deadlines while maintaining high-quality deliverables.
- Excellent written and verbal communication skills.
- Ability to work effectively and collaboratively with biostatistics, data management, and other cross-functional teams.
ResponsibilitiesPosition OverviewProvide expert-level, hands-on statistical programming support across clinical and device studies, regulatory submissions, exploratory analyses, and other internal business needs. This role will also contribute to programming quality, standardization, and innovation within the department.
Primary Responsibilities - Provide expert-level statistical programming support for clinical and device studies, including CSRs, ISS/ISE analyses, exploratory data analyses, and other study-related deliverables.
- Develop, validate, and maintain SAS programs to generate SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TLFs).
- Write, review, and approve specifications for SDTM and ADaM datasets.
- Perform thorough quality control (QC) of programming deliverables to ensure accuracy, consistency, and compliance with applicable regulatory standards.
- Support regulatory submissions, including preparation and review of submission-ready datasets and related documentation.
- Collaborate closely with biostatistics, data management, and cross-functional teams to support clinical trials, regulatory submissions, publications, and other business initiatives.
- Develop, validate, and maintain departmental standard macros, reusable programs, and programming templates.
- Identify and implement innovative programming strategies, tools, and process improvements to increase efficiency and quality.
- Provide programming support for publication requests and other exploratory analyses as needed.
- Ensure all programming activities adhere to departmental SOPs, established guidelines, CDISC standards, and applicable regulatory requirements.
- Manage multiple projects and competing priorities while maintaining high-quality, timely deliverables.
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