Senior Biostatisticians, Little Falls, New Jersey, USA (on-site and remote) Location
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 Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. 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 Senior Biostatisticians for our Little Falls, New Jersey, USA (on-site and remote) location.
This position is accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.
- Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others.
- May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but not limited to, the following:
- Providing leadership/expertise in research and development of statistical methodologies.
- Investigating and implementing new technologies, processes and procedures.
- Developing and executing customer relationship management plans.
- Participating in new business development and bidding processes.
- Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.
- Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables.
- Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.
- Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.
- Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.
- Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications.
- Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.
- Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.
- Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.
- Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.
- Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.
- Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.
- Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.
- Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.
- With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
- Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.
- Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.
- Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.
- Plan and carry out professional development.
Qualifications and Experience:
A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 5 years relevant experience or a master’s degree plus 8 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.
How to Apply:
Please send your application along with cover letter to [email protected]
To find out more about Everest Clinical Research and to review other opportunities, please visit our WEB site at www.ecrscorp.com
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.