Senior Biostatistician

Everest Clinical Research; Rickmansworth; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Biostatistician to work remotely in the UK. The role involves statistical planning, programming, and analysis for clinical trials. Candidates should hold a Ph.D. or Master's in a related field with relevant experience.

Qualifications

• Ph.D. plus 2 years or Master's plus 4 years of relevant experience.
• Demonstrated ability and performance in statistical analysis.

Responsibilities

• Lead statistical and programming operations, ensuring quality and efficiency.
• Provide statistical expertise for clinical trials and research projects.
• Perform statistical analysis as per SAP and contribute to CSR.

Skills

Leadership

Statistical Planning

Statistical Programming

Statistical Analysis

Education

Ph.D. in statistical science

Master’s degree

Job description

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 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 working remotely from a home-based office in the United Kingdom, in accordance with our Work from Home policy.

Key Accountabilities:

1. Leadership and Project Management: Lead efforts in resolving day-to-day work-related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on-time delivery of deliverables, earn client’s trust, and secure repeat business.
2. Statistical Planning and Methodologies: Provide statistical expertise for design, analysis, and reporting of clinical trials and research projects. Contribute to the writing of statistical sections of study protocols, perform sample size calculations, develop randomization specifications, and generate randomization codes. Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments. Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects. Provide input to unblinded data management plans when required. Assist in research and development of statistical methodologies and processes.
3. Statistical Programming: Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required. Perform QC validation of analysis datasets and TLGs. Perform third-level review of dry runs and final runs. Lead statistical dry runs and final runs by actively participating or contributing to project and resource management, addressing statistical and programming questions, and interacting with data management to follow up and resolve data issues. Review and provide input to the Analysis Data Reviewer’s Guide, discuss, and incorporate Data Standards Reviewer's review comments to ensure quality of the document.
4. Statistical Analysis, Reporting, and Publication Support: Perform statistical analysis as per SAP, address peer/QC review comments and findings. Conduct statistical validation of core results, address additional QC validation comments, and findings on the core results. Plan and conduct or contribute to trial results reporting/dissemination meetings. Contribute to the contents describing any deviations from the planned analysis and study conduct for the Clinical Study Report (CSR). Review CSR for accuracy, completeness, and appropriate interpretation of statistical results. Write statistical reports or sections of the CSR. Perform statistical analyses for publications, including abstracts, manuscripts, presentations, and posters.
5. Supporting Clinical Data Collection and Cleaning: Provide statistical input to CRF design and database/variable structure. Provide statistical input to non-CRF data collection and acquisition methods. Review Data Management Plan sections related to critical data collection and cleaning. Provide statistical input to Data Validation Specifications. Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution. Perform ongoing assessment and communication of data quality issues, including protocol deviations. Assist data management and trial teams in preparing for database lock. Complete job-specific training and comply with Everest and sponsor policies, SOPs, and work instructions. Properly archive study files according to sponsor requirements. Plan and carry out professional development activities.

**Qualifications and Experience:**

A Ph.D. in statistical science, mathematical analysis, or related fields plus 2 years of highly relevant experience, or a Master’s degree plus 4 years of highly relevant experience, with demonstrated ability and performance.

To learn more about Everest Clinical Research and explore other opportunities, 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 dignity, independence, integration, and equal opportunity. We welcome applications from people with disabilities and will provide accommodations upon request during the recruitment process.