Senior Statistical Programmer
New
J
JobgetherClinical research
Listing location: India; Workplace type: Remote; Structured job location: IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Professional fluency in English
Requirements
- Bachelor’s degree, preferably in a scientific, statistical, mathematical, or related discipline; equivalent combinations of education and relevant professional experience are also considered.
- Extensive hands-on experience in statistical programming using SAS or other relevant programming software, preferably within clinical trials or the pharmaceutical industry.
- Strong knowledge of clinical trial data, statistical programming methodologies, and clinical study outputs.
- Experience developing, validating, and reviewing complex datasets, tables, listings, and figures.
- Previous experience leading statistical programming activities, coordinating project deliverables, or providing technical guidance to programmers.
- Familiarity with Statistical Analysis Plans, annotated CRFs, mock shells, and programming specifications.
- Good understanding of clinical research quality standards, regulatory requirements, SOPs, and ICH guidelines.
- Strong analytical, problem-solving, and troubleshooting abilities with attention to detail.
- Strong organizational and time-management skills, including managing multiple projects, deadlines, and changing priorities.
- Professional fluency in English, including reading, writing, speaking, and understanding technical and project-related documentation.
- Willingness to undertake occasional business travel when required.
Responsibilities
- Develop and maintain statistical programming code using SAS or other relevant software to produce tables, listings, figures, and derived datasets.
- Perform independent validation programming and quality control of statistical outputs.
- Review Statistical Analysis Plans, mock shells, annotated CRFs, programming specifications, and database designs.
- Lead programming activities across clinical projects, coordinating deliverables and monitoring timelines and quality.
- Develop programming specifications for datasets and outputs of varying complexity.
- Maintain inspection-ready project documentation, including testing records, verification reports, and quality control documentation.
- Collaborate with biostatisticians, programmers, and project teams to investigate discrepancies and resolve technical issues.
- Manage priorities and delivery timelines across multiple projects.
- Represent statistical programming in sponsor meetings, project kickoffs, and bid defense meetings when required.
- Mentor junior programming professionals and contribute to continuous improvement and efficient programming practices.
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