Manager, Biostatistics

Everest Clinical Research ( Everest ) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.

We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.

Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs.

A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength that’s us that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Manager, Biostatistics for our Little Falls, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Key Accountabilities :

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.

Lead statistical and programming teams and 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 and testing, and 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 including, but not limited to, the following : electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Management Plan, and Data Review Plan (and the ongoing data review tables, listings, and figures TLFs in accordance with the 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. Perform quality control (QC) activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.

Perform hands on statistical analysis and modeling; maintain 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 the clients.

Provide statistical consultation to medical and clinical trial personnel for the publication of trial results; participate 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, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to programs / projects.

Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates by contributing to the performance evaluation process.

Act as a consultant to less experienced Biostatisticians.

Ensure 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, but not limited to, the following : provide cost estimates of statistical and programming services, participate in generation of project proposals and bid defense meetings, and participate 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, provide cost estimates, and draft change orders to existing service work orders.

Qualifications and Experience :

A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 5 year’s relevant experience

A Master’s degree in the above fields with at least 8 year’s relevant experience, with demonstrated exceptional ability and performance.