Principal Biostatistician

Job not on LinkedIn

🕒 March 27

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $150k - $200k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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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 leader of the Statistical Operations management team 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. • Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting. • Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects. • Provide statistical input in protocol design and development. • Participate in the writing of trial protocols and research proposals. • Serve as a primary 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, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan. • Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. • Perform peer review of SAPs and other technical documents written by others. • Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements. • Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. • Perform overall Quality Control review on statistical deliverables before they are released to the clients. • Review and confirm ADaM dataset specifications. • Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians. • Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations. • Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions. • Interact with regulatory agencies and support sponsor in new drug application.

🎯 Requirements

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience or a Master’s degree in these fields with at least 10 years of relevant experience, with 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) • a 401(k) retirement / pension plan • generous paid time off and sick leave • opportunity to earn a performance based bonus