Senior Specialist, Centralised Statistical Monitoring

The Senior Specialist, Centralised Statistical Monitoring is responsible for the implementation of Centralised Monitoring services in large, multi-site clinical studies. This role is particularly, although not exclusively, focused on Centralised Statistical Monitoring (CSM). The individual needs to have a solid background in statistics and data analysis in clinical development, and an understanding of using statistical techniques for investigating data integrity

Typical Accountabilities:

• Executes the implementation of CSM service that is aligned with Development Operations and Clinical Data & Insights organization vision
• Cooperates with and supports Associate Director, CSM (AD CSM) and other roles in CM team in development and maintenance of CSM processes, standards and framework
• In consultation with clinical study teams, helps develop the CSM strategy and plans for individual clinical studies and development programmes.
• Carries out CSM at defined points in the trials and report on findings to the study statistician and study team (analysis are aimed to identify non-random errors or patterns that may be the result of data integrity issues such as GCP misconduct, including fraud, e.g.: Fabricated or omitted data, Lack of precision or mis-calibrated equipment, Incorrect randomizations (e.g. failure of inclusion/exclusion criteria), Patients enrolling at multiple sites (professional subjects))
• Performs further investigations on potential data integrity issues.
• Produces CSM analysis plans and CSM reports & appendices for each defined timepoint.
• Provides quality control and validation support for CSM plans, analyses and reports, as appropriate.
• Leads quality of own deliverables
• Assists AD CSM and other roles in CM in the development and implementation of new statistical methods for CSM and RbQM, collaborating with study teams to understand the importance of different variables, critical-to-quality factors and key risk indicators
• Interacts with external vendors providing CSM tools and advice on the CSM implementation strategy.
• Can contribute to function by training and mentoring of more junior staff

Essential

• MSc or PhD biostatistics, mathematics, informatics, computer science, the physical sciences or related subject
• Experience of clinical drug development statistics & the pharmaceutical environment
• Understanding of GCP and regulatory requirements as they relate to Risk Based Monitoring, Risk Based Quality Management and Centralised Statistical Monitoring
• Understanding of CSM and RbQM, and their impact on study conduct & integrity, interpretation of extreme / outlying and missing data
• Experience of programming and data handling using SAS software
• Knowledge of CDISC SDTM and ADaM standards
• Demonstrated project management skills for own workload
• High attention to detail and accuracy Solid organizational and analytical skills
• Ability to work independently
• Ability to work and interact effectively with external partners
• Strong written and verbal communication skills in English

Desirable

• Experience of advanced innovative statistical techniques for CSM
• Experience of programming and data handling using R
• Experience of JMP/Clinical software
• Experience of main therapeutic areas: Oncology, Immuno-Oncology, Respiratory, Inflammation & autoimmunity, Cardiovascular, Renal & Metabolic diseases
• Excellent collaboration – needs the energy, tact and influence to work successfully across global & functional boundaries
• Analytical thinking
• Diligence – attention to detail and ability to project manage multiple concurrent activities