Senior Statistical Programmers, Shanghai, China (on-site) 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 global CRO. 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.
To drive continued success in this exciting field of clinical research, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Statistical Programmers in our Shanghai (Pudong Zhangjiang New District), China office.
This position is expected to perform a leadership role in statistical programming and reporting areas. Incumbents in this role receive highly competitive compensation and benefits. Highly driven, team-oriented, and quality-focused individuals have the potential to advance to technical or business leadership positions.
Tasks are performed in a timely, accurate, and efficient manner to ensure quality and productivity. Deliverables will conform with regulatory submission standards from CDISC, FDA, EMA, CFDA, PMDA, and other regulatory agencies. These tasks may include, but are not limited, to the following:
- Lead study teams by participating in resource planning and managing timelines and deliverables. This includes managing programming assignments for project team members and following up on task status to ensure deliverables are completed on time and with quality.
- Prepare SDTM data mapping specifications, ADaM dataset specifications, data reviewer’s guides and define.xml documents. Perform QC review of these documents prepared by others.
- Program SDTM and ADaM datasets according to approved dataset specifications.
- Generate complete and accurate statistical tables, listings, and graphs (TLGs) in accordance with Statistical Analysis Plan (SAP) and well-defined formats.
- Document data and programming information in accordance with SOPs and/or clinical trial sponsor’s specific requirements.
- Perform independent SAS programming validation of datasets and TLGs programmed by others.
- Perform 3rd level QC review and programmatic checks on programming deliverables before releasing them to clients.
- Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
- Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements.
- Actively contribute to the continuous improvement of clinical data standards, conventions and statistical programming SOPs.
- Design and implement SAS macros to enable standardization and efficiency in statistical programming.
Qualifications and Experience:
- A Master’s degree in Statistics, Biostatistics, Bioinformatics, Computer Sciences, Mathematics, or other relevant fields is required with at least five years of relevant industry experience using SAS in clinical trial analysis and reporting.
- A College English Test (CET) 6 certificate is highly preferred.
- In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis.
- Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented to regulatory agencies.
- Knowledge of clinical trial regulatory, ICH GCP, and CDISC requirements.
- Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data/results with documentation to regulatory agencies.
- Strong leadership skills, commitment and drive to achieve goals.
How to Apply:
Please send your application along with cover letter to [email protected] or to the job agency representing Everest Clinical Research.
To find out more about Everest Clinical Research and to review other job opportunities, please visit our website 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.