Clinical Trials Statistician
The Cancer Research UK & King’s College London Cancer Prevention Trials Unit (CPTU) specialises in research to advance cancer prevention, early diagnosis and screening. We perform research on efficacy, cost-effectiveness and technologies to improve existing and establish new screening programmes.
Our portfolio of both secondary (hospital) and primary (community) care trials includes:
• Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug re-purposing
• Pragmatic trials of screening and diagnostic interventions
• Trials of behavioural interventions in cancer prevention and screening
• Trials of diagnostic/screening devices
About the role:
We are looking for an enthusiastic trial statistician to join the expanding CPTU team to provide statistical support for our cancer screening research projects.
You will be the trial statistician on projects including the revolutionary NHS-Galleri trial: a randomised controlled trial of a multi-cancer early detection test with GRAIL Bio UK Ltd, NHS England and NHS Improvement. Over 700,000 people across England will be invited to receive a novel CE-marked, blood test for the presence of over 50 cancers intended to identify cancer at an early treatable stage. This is a unique opportunity to be involved with a potentially game-changing project of nationwide importance.
We have other new exciting projects in prevention and early detection of prostate, bladder and cervical cancer often undertaken in collaboration with leading experts and research bodies across the UK.
The successful applicant will join The CRUK & King’s College London Cancer Prevention Trials Unit under the leadership of Professor Sasieni at King’s College London.
The post holder will be a statistician with a strong interest in clinical trials. You will be primarily working on analyses of data from cancer screening trials and other studies in cancer prevention. This will require a good understanding of statistical methods and fluency in using statistical software (e.g. R and/or Stata). You will have excellent organisational and planning skills with an intrinsic interest in improving the health and well-being of communities through translational research and evidence-based innovation.
You will oversee statistical activities for major projects, supporting the development of trial protocols and statistical analysis plans, preparing reports for data monitoring committees and being responsible for carrying out interim and main statistical analyses. You will lead on the tables, listings, and figures (TLFs) displaying all study data and results in the clinical study report (CSR).
Contributions to applied analyses or methodological development will be recognised through authorship on publications. Opportunities will also be provided for further professional development.
The person appointed will report to and be supervised by Dr Bernard North, Senior CPTU Statistician, and will work closely with trial teams and data managers.
This post will be offered on an a fixed-term contract until end of Apr 2024 in the first instance
This is a full-time post - 100% full time equivalent
- To contribute to study design, data manipulation, writing statistical analysis plans, undertaking statistical analyses, interpretation of results and solving statistical problems that may arise.
- To contribute to the preparation of clinical study reports
- To contribute to the writing and publication of high-quality papers in peer-reviewed literature and the dissemination of research findings.
- To maintain accurate written and computerised records and to maintain confidentiality of all electronically stored personal data in line with relevant information governance policies and ensure confidentiality on all matters and information obtained during the course of employment.
- To contribute to the development and dissemination of sound methodology appropriate to the group’s portfolio of studies.
- Work, where applicable, with the Sponsor, Chief Investigator(s), grant co-applicants, data managers, monitors, clinicians, statisticians and trial oversight committees and external agencies on a daily basis to ensure the project milestones are met
- Responsible for the development of statistical procedures for the conduct of the protocol
- Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and quality standards and that appropriate records and audit trails are maintained
- Prepare trial reports as required
- Work closely with the trial and data managers to ensure timely data entry and cleaning and to ensure satisfactory resolution
- Approve case report forms to ensure all relevant data is collected to answer the research objectives
- Support the data managers to decide what steps need to be taken to correct any missing, contradictory or incorrect data and ensure that these problems are followed through to a satisfactory conclusion within a reasonable timescale
- Ensure that the collection of trial data is complete, accurate and up to date for analysis according to agreed deadlines.
- The post-holder will be expected to work both independently in planning day-to-day activities (in accordance with the projects’ deadlines as agreed with their supervisor) and as part of a multidisciplinary research team.
- Any other duties appropriate to the grade as directed by the line manager and CPTU Head of Operations
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
1. Degree-level qualification in statistics, mathematics or with a substantial statistical and data analysis content
2. PhD with high statistics content or have equivalent experience
3. A solid understanding of statistical concepts especially when applied to biomedical research and ability to learn additional advanced statistical methods.
4. A strong background in clinical trial design, conduct, analysis and interpretation
5. Excellent written and verbal communication skills, including ability to convey statistical concepts to a non-statistical audience
6. Proficiency in using statistical software (ideally Stata or R) and willingness to learn new software (e.g. Stata if not already known).
7. Experience in manipulating data sets and in analysing research data
8. High level of accuracy and attention to detail
9. Highly motivated, hardworking, adaptable, problem-solving with a high level of accuracy and attention to detail
10. Ability to work both independently and as part of a multidisciplinary team
11. Peer-reviewed publications
1. Knowledge of the use of genetic and epigenetic biomarkers particularly in cancer diagnosis and prognosis.
2. Knowledge of cancer diagnostic and treatment pathways and data repositories.
3. Knowledge of the development and assessment of clinical prediction models.
4. Experience working as a statistician in a research environment (academic or commercial)
Please contact Bernard.firstname.lastname@example.org@kcl.ac.uk
This post is subject to Disclosure and Barring Service clearance.