Biostatistics Manager

Everest Clinical Research is a leading contract research organization (CRO) providing a wide range of clinical research services to the pharmaceutical, biotechnology, and medical device industries.

We are seeking a highly skilled and experienced Manager, Biostatistics to join our team in Little Falls, New Jersey, USA, or remotely from a home-based office anywhere in the USA.

• Manage clinical trial programs/projects from one or multiple clients, working closely with the Statistical Operations management team.
• Provide technical and operational leadership to project teams, ensuring the delivery of high-quality statistical and programming services.
• Lead statistical and programming teams, interacting with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans.
• Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, data handling, statistical modeling and testing, and analysis and reporting.
• Provide statistical input in protocol design and development, participating in the writing of trial protocols and research proposals.
• Serve as a principal-level Biostatistician, contributing strategically to drug development and commercialization at the study and drug compound/therapeutic areas levels.
• Review and provide input to clinical data management deliverables, including electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Management Plan, and Data Review Plan.
• Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
• Perform peer review of SAPs and other technical documents written by others.
• Review and confirm ADaM dataset specifications, performing quality control (QC) activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
• Perform hands-on statistical analysis and modeling, maintaining expertise in state-of-the-art statistical methodology and regulatory requirements.
• Validate core statistical TLFs programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate.
• Perform overall QC review on statistical deliverables before they are released to clients.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, participating in the writing of abstracts, manuscripts, posters, and presentations.
• Coach, mentor, develop, and provide technical review, advice, and expertise to direct subordinate Biostatisticians and Statistical Programmers.
• Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates.
• Act as a consultant to less experienced Biostatisticians, ensuring all study level and drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
• Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
• Participate in the continuous improvement and maintenance of statistical and programming governing documents.
• Assist in business development activities, including providing cost estimates of statistical and programming services, participating in the generation of project proposals and bid defense meetings, and participating in professional trade shows when required.
• Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.
• Perform tracking of out-of-scope services on assigned projects, providing cost estimates, and drafting change orders to existing service work orders.

• A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 5 years of relevant experience.
• OR A Master's degree in the above fields with at least 8 years of relevant experience, with demonstrated exceptional ability and performance.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.

We welcome and encourage applications from people with disabilities, and upon request, we will provide accommodations for candidates participating in any part of our recruitment and selection process.