Associate Director, Biostatistics

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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

• Will be a lead statistician on individual studies, across related studies, and for integrated summaries. • Design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. • Responsible for all statistical aspects of study design, study analysis, validation, and documentation. • Provide timely and scientifically sound statistical expertise to clinical development projects. • Develop and execute statistical strategy, design, and analyses for clinical trials. • Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.

🎯 Requirements

• MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 7 years of experience in pharmaceutical or biotechnology industry. • PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry. • Knowledge of drug development regulations pertinent to statistical analysis. • Knowledge of the oncology or hematology therapeutic area is preferred. • Bayesian and adaptive design experience is preferred. • Proficient SAS & R programming skills, solid understanding of CDISC models and standards. • Excellent writing and communication skills. • Demonstrated leadership abilities and excellent interpersonal skills.