Principal Statistical Programmer

Job not on LinkedIn

🔥 1 hour ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 25%

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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 with concept-level instruction and very little supervision • Track progress and provide expert technical support to team members • Work on clinical development programs across different therapeutic areas • Participate in overseeing CRO programmers to ensure consistent, high-quality data summaries • Implement reporting and analysis activities for Sponsor clinical trials • Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies • Develop SAS programs generating datasets, complex listings, tables, descriptive and inferential statistics, and complex graphs • Develop, validate, and maintain SAS and/or R programs for clinical development programs • 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 • 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

🎯 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 regulation • Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities • Must be able to work independently • Outstanding written and verbal communication skills and strong leadership skills • Preferred: prior work experience with pharmacokinetic data and the neuroscience field • Preferred: proficiency in tools other than SAS, such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git

🏖️ Benefits

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