One of our partners is looking to build upon recent success and expand their clinical department, and we are supporting them in their search for a Senior Biostatistician.

This is a long term contract opportunity.

As well as being expert in Statistics, you will have the opportunity to train, mentor and support other members of the statistics and SAS programming team.

The organisation focus within Haematology and Cardiovascular projects and currently have new studies in start-up phase; current projects including high profile large cardiovascular registry studies.

AS the Senior Biostatistician you will ensure studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory guidelines.

Manage trial/project responsibilities independently. Handle 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.

Here's a snapshot of what you will be doing :

• Collaborate 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.
• Perform 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.
• Document 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.
• Discuss 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
• Lead 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.
• Contribute 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.

You should recognise yourself here:

• 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 relevant 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

All candidates will need to have current and valid eligibility to work in the UK in order to be considered for this role. This role is 100% office based so please keep that in mind before applying.

If you have any questions or you would like more information on the role then call Bryan on 01273 729819 or email bryan@pop-science.co.uk

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

Find out more at Pop Science - Recruitment