Senior/Principal Statistical Programmer FSP

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🕒 June 24

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you. • The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. • Responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. • Participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.

🎯 Requirements

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred • 5+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment • Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities • Must be able to work independently • Outstanding communication skills (written and verbal) and strong leadership skills.

🏖️ Benefits

• Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. • Consistent training, development and support.