Associate Director, Biostatistics

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🕒 April 2

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects from one or multiple clients. • Provide day-to-day technical and operational leadership to project teams supporting these programs/projects. • Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects. • Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process. • Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables. • Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting. • Provide statistical input in protocol design and development. • Participate in the writing of trial protocols and research proposals. • Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels. • Review and provide input to clinical data management deliverables. • Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs). • Perform peer review of SAPs and other technical documents written by others. • Validate core statistical tables, listings, and figures programmed by Statistical Programmers and/or Biostatisticians. • Perform overall quality control (QC) review on statistical deliverables before they are released to the clients. • Provide statistical consultation to medical and clinical trial personnel for the publication of trial results.

🎯 Requirements

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 10 years’ relevant experience or a Master’s degree in these fields with at least 13 years’ relevant experience. • Demonstrated exceptional ability and performance.

🏖️ Benefits

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • pension plan • generous paid time off and sick leave • opportunity to earn a performance based bonus