Principal Statistical Programmer

Job not on LinkedIn

🔥 14 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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👻 Ghost score 23%

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Work independently on clinical development programs across different therapeutic areas • Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies • Develop SAS and/or R programs producing datasets, complex listings, tables, descriptive and standard inferential statistics, and complex graphs • Develop, validate, and maintain statistical programming programs tailored to clinical development needs • Oversee CRO statistical programming deliverables for multiple clinical studies • Support clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses • Follow FDA regulations, good clinical practice, and electronic-submission guidelines for clinical trial data reporting • Create, maintain, document, and validate standards for programming tools, outputs, and macros • Participate in developing CRFs, edit check specifications, and data validation plans • Review and/or author data transfer specifications for external vendor data • Collaborate with CROs, software vendors, clinical development partners, and internal functions to meet project timelines and goals • Review and/or author SOPs and work instructions related to statistical programming practices • Provide expert technical support to team members and track progress

🎯 Requirements

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team • Experience supporting drug development, medical device development, or intervention studies • Exceptional SAS programming skills and expertise in developing and implementing statistical programming procedures and processes in a clinical development environment • Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations • Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities • Ability to work independently • Outstanding written and verbal communication skills and strong leadership skills • Preferred: prior experience with pharmacokinetic data and neuroscience • Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, and git

🏖️ Benefits

• Consistent training, development and support • Significant professional growth opportunities