Associate Director, Biostatistics

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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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

• Lead statistical activities for assigned clinical trials, mainly Phase 3, from protocol design through reporting of results • Represent the Statistics function on cross-functional trial teams • Oversee internal programming activities and/or CRO contributions • Contribute to or lead database lock, submission activities, safety reporting, ad hoc requests, and responses to regulatory questions • Collaborate with clinical, data management, programming, and other stakeholders to develop and finalize study outputs • Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses • Coordinate statistical activities across studies to align objectives, ensure consistency, and deliver on time • Formulate integrated analytical approaches, apply statistical methods and machine learning/deep learning algorithms, and automate repeatable processes

🎯 Requirements

• Master’s degree in Statistics or related quantitative discipline; PhD preferred • 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry • Solid recent experience (≥3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review • Strong knowledge of adaptive design, group sequential and statistical methods of count data • Prior experience on Hematology studies preferred • Good understanding of the drug development process and cross-functional interfaces • Experience supporting end-to-end trial delivery, from protocol input through CSR contributions • Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions • Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams • Excellent and effective communication skills and ability to interact effectively with cross-functional stakeholders and external partners • Strong organizational and project management skills • Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables

🏖️ Benefits

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