Will ensure TRI studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, TRI SOPs and all applicable regulatory guidelines. Manages trial/project responsibilities independently. Handles multiple competing projects and deadlines, and coordinates all the statistical needs of each clinical trial/project. Performs intermediate and advanced statistical analysis and programming for clinical research projects with particular emphasis on analyses based on clinical trial data, electronic health record data and other novel data sources.
- Collaborates with clinical investigators to translate clinical goals into questions that can be answered using available data and statistical techniques. With minimal or no guidance, prepares statistical analysis plans for abstracts or manuscripts targeted to a clinical audience while incorporating input from statistician mentors and from clinical collaborators.
- Performs and interprets basic and complex analyses without guidance. Uses statistical and medical understanding to propose and perform additional analyses appropriately and independently. Learns new statistical methods as needed, and applies new skills to future projects. Serves as a resource for other statisticians about a broad spectrum of analysis methods.
- Documents analyses, creates summaries, and presents results in written and verbal form to requestors. Writes statistical text for study reports and clinical publications. Able to work on any phase of a manuscript project, from initial meeting with an investigator to final review of a manuscript prior to submission for publication (checking presentation of results for accuracy and appropriate interpretation) and responding to reviewer comments.
- Discusses analytic issues related to other findings within a project. Independently and proactively assesses how project results fit in the context of results from similar projects in the broader field. Contributes meaningfully and creatively to discussions of analyses with clinical investigators and other statisticians and proactively identifies next steps for analyses
- Leads or participates actively in the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products. Collaborates effectively with statistical programmers, informaticists and data managers who support their projects. Identifies potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution. Demonstrates understanding of project data collection processes and data sets and shares knowledge with collaborators.
- Contributes to the thought process of endpoint selection and study design. Calculates samples sizes, and power calculations without guidance. Drafts statistical sections for study synopses and protocols, without guidance.
- Proficient in SAS and/or R; finds errors, corrects, and validates output and results. Performs complex programming efficiently, uses complicated SAS and/or R procedures and options. Programs analysis datasets using SAS and/or R and/or reviews those programmed by others to ensure quality products; combines multiple disparate raw databases and derives analysis variables accurately. Uses complicated SAS and/or R procedures and options and programs with increasing efficiency. Considers alternative programming approaches to improve quality and/or efficiency. Possesses broad programming abilities and shares them with others by consultation and example and maintains programming skills even when delegating many programming tasks to others.
- Handles and secures highly confidential and sensitive analyses and documentation. Learns IT tools and analytical methods appropriate for projects. Collaborates closely with clinical investigators, other statisticians and statistical programmers to share and document this knowledge.
- Guides all statistical aspects of a project without guidance. Collaborates with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the project, and to jointly achieve objectives and timelines. Represents the functional group in project team meetings and contributes constructively to project discussions. Understands the contracted scope of work and estimates hours and resources expected to complete each project. Proactively identifies potential out-of-scope activity and brings to the attention of project leader, and follows up as needed to ensure that it is addressed in a timely manner. Creates timelines for statistical project management without assistance.
- Adheres to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics. Understands and proactively remains abreast of guidelines from the regulatory agency as they apply to statistics, programming, and handling of clinical data; monitors compliance to required standards of own work and that of any individuals being mentored. Demonstrates solid understanding of the clinical drug and/or device development process.
- Collaborates effectively with a variety of types of individuals: programmers, statisticians (both junior and senior), medical personnel, and representatives within the business community. . Consistently demonstrates leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects
- Consistently handles multiple competing projects and deadlines. Presents information on topics relevant to statistics and statistical operations at internal statistics meetings. Gives oral presentations of key statistical methods, operational issues, study results, or project status at trial or clinical project meetings.
- Learns about clinical aspects of the research, as appropriate.
- Performs other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this role. This is not intended to be an exhaustive list of all responsibilities and duties required of the role holder.
Desired Skills and Experience:
- Track record experience in Real World Evidence, large observational healthcare datasets
- Experience within an epidemiological, health economics or outcomes research group
- Comfortable with working with large data sets
- Role requires a minimum of a Doctoral degree in (bio) statistics or related field and 0-2 years relevant experience, or a master’s degree in (bio) statistics or related field and 4 years relevant experience, or a bachelor’s degree in (bio) statistics or related field and 6 years relevant experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
- Expert in SAS programming
- Statistical methods: survival analysis, time-dependent Cox model, multiple imputation, logistic regression, Poisson regression, models for count data and smoothing techniques
- Experience as a lead statistician on clinical trials and/or clinical research projects that have consistently provided high quality end products on time, and prior supervision and/or guidance of lower level or less experienced employees is required
Candidates will need to have current and valid eligibility to work in the UK in order to be considered for this role.