Statistician – Job Description

Reports to: Director / Senior Statistician

Direct Reports: None

Role and responsibilities:

• Develop SAS Programs to produce tabulations, graphics, listings, datasets and statistical analysis of clinical trial data to meet client requirements
• Perform QC on tabulations, graphics, listings, datasets and statistical analysis on work by other team members
• Work as part of a team to complete the reporting of clinical trial data in an efficient manner for inclusion in statistical or other relevant reports
• Liaise with functional groups and client to understand and help define requirements
• Review and contribute to relevant documentation (e.g. statistical analysis plans, protocol, CRF)
• Deliver assigned tasks on time, efficiently and to required quality
• Provide effective and timely communication with line manager and relevant project personnel regarding all aspects of day-to-day work
• Familiarise themselves with Numerus's SOPs, as well as statistical, regulatory and therapeutic guidance documents (e.g. ICH/GCP), areas
• Create clear documentation relating to assigned tasks
• Perform, present and interpret data manipulations and statistical analyses
• Derive statistical conclusions and make recommendations based on experimental results
• Provide input into Statistical analysis plan (SAP) development with assistance

Qualifications and experience:

• MSc (or equivalent) in Statistics or a BSc in Statistics plus relevant experience
• Ideally relevant experience within CRO or pharmaceutical/clinical trials environment
• Understanding of statistical methods within the context of clinical and/or epidemiological trials
• Knowledge of SAS beneficial
• Proven ability to organise workload and complete tasks on time
• Demonstrated ability to work effectively in team environment

Personal attributes:

• Strong interpersonal skills and ability to communicate effectively
• Ability to be flexible with respect to changing priorities and type of work
• Ability to prioritise and manage multiple tasks
• Excellent organisational and analytical skills
• Excellent inter-personal and team work ability
• Excellent communication and presentation skills
• Excellent knowledge of spoken and written English

Senior Statistician – Job Description

Reports to: Director

Direct Reports: Statistician

Role and responsibilities:

• Develop SAS Programs to produce tabulations, graphics, listings, datasets and statistical analysis of clinical trial data to meet client requirements
• Perform QC on tabulations, graphics, listings, datasets and statistical analysis on work by other team members
• Statistical analysis plan (SAP) and shell development with minimal assistance, as well as performing QC of SAPs
• Work as part of a team to complete the reporting of clinical trial data in an efficient manner for inclusion in statistical or other relevant reports
• Liaise with functional groups and client to understand and help define requirements. Assist the Directors with work orders, contracts and estimates of time required for projects
• Review and contribute to relevant documentation (e.g. statistical analysis plans, protocol, CRF)
• Deliver assigned tasks on time, efficiently and to required quality
• Provide effective and timely communication to the line manager and relevant project personnel regarding all aspects of day-to-day work
• Familiarising themselves with the drug development process Numerus's SOPs as well as statistical, regulatory and therapeutic guidance documents (e.g. ICH/GCP)
• Create clear documentation relating to assigned tasks
• Perform, present and interpret data manipulations and statistical analyses
• Derive statistical conclusions and makes recommendations based on results
• Perform Lead Statistician activities for allocated projects. Contributes knowledge and expertise to manage the team and the client to ensure study milestones are met, to the right quality and profitability
• Contributes within programming to current and future resourcing assessments, to ensure studies are delivered on time, to budget and profit levels. Proactively identifies, justifies and manages changes in scope that would impact timelines and budgets. Accurate tracking and forecasting of expenditure. Ensures high quality of individual and team deliverables - protocol, study start-up activity, SAP, reporting and publication deliverables..
• Ensuring statistical reports meet regulatory and company standards
• Develop knowledge in the use of SAS (e.g. macros, statistical procedures) and other in-house reporting systems
• Develop knowledge in the set-up and use of the reporting environment
• Provide training/guidance to less experienced statisticians
• Perform exploratory stats using advanced techniques
• Line reporting of Statisticians

Qualifications and experience:

• PhD, MSc (or equivalent) in Medical Statistics or a BSc in Statistics and relevant clinical trials experience
• Proven experience within CRO or pharmaceutical/clinical trials environment
• Understanding of statistical methods within the context of clinical and/or clinical pharmacology trials
• Knowledge of SAS essential
• Considerable hands-on Statistical experience
• Knowledge of different phases and types of clinical trial reporting (e.g. Phase I-IV, Clinical Study Reporting, ISS/ISE including e-sub activities) as well methods used for reimbursement and epidemiology
• Excellent understanding of skills and goals of reporting clinical data
• Prior experience of training and mentoring of others in this field
• Demonstrated ability to manage own and other people’s workloads
• Broad understanding of statistical methods within the context of clinical and/or clinical pharmacology trials

Personal attributes:

• Strong interpersonal skills and ability to communicate effectively
• Ability to be flexible with respect to changing priorities and type of work
• Ability to prioritise and manage multiple tasks
• Excellent organisational and analytical skills
• Excellent inter-personal and team work ability
• Excellent communication and presentation skills
• Excellent knowledge of spoken and written English