Associate Director, Biostatistics FSP

Job not on LinkedIn

🔥 6 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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

• Support statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocol design, SAPs, clinical study reports, regulatory documentation, and associated publications • Oversee production of biostatistics deliverables, including planned, post-hoc, and exploratory analyses, performed by external resources • Provide statistical strategy support and input for protocols, CSRs, scientific presentations, and manuscripts • Review randomization procedures and oversee production of randomization lists • Review study Case Report Forms, data management plans, and related documentation to ensure statistical requirements are met • Oversee outsourced statistical CRO activities and deliverables, ensuring high-quality and timely delivery • Produce innovative tools and methodologies for statistical analysis through literature review • Participate in department strategies and cross-functional initiatives concerning standards, infrastructure, and processes

🎯 Requirements

• Master’s degree in Statistics or a related field • 7+ years of experience in statistical analysis within the biotech/pharmaceutical industry • Experience with a broad array of statistical approaches • Experience proposing novel approaches to support acceleration of clinical programs • Knowledge of machine learning and artificial intelligence is a plus • Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice • Strong statistical programming skills in R, SAS, and Python • Understanding of regulatory guidelines related to submission of datasets using CDISC • Experience developing SDTM and ADaM specifications • Strong vendor management experience • Previous experience in Neuromuscular, Ophthalmology, or related therapeutic areas is preferred • Excellent verbal and written communication skills • Strong attention to detail and proactive mindset • Ability to work independently, take ownership, and be accountable for study- and program-level statistical activities and deliverables

🏖️ Benefits

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