Closing date for applications: 31 May 2021
MAC Clinical Research manages clinical trials for the pharmaceutical industry and we are seeking to appoint a Principal Statistician to join our biometrics team and make a positive impact in a world-leading Clinical Research Organisation.
We are happy to be flexible with regards to location in the UK, so any of our clinical site locations may be considered with the option of home working.
This role would suit candidate with background or keen interest Statistics in a CRO environment.
This role combines project leadership and line management with a hands-on technical statistics role. Working across a range of phases and therapeutic areas, the Principal Statistician will lead assigned studies, ensuring they are delivered to optimal quality, on time and on budget.
Provide leadership to the Biostatistics department and the Statistical team assigned to individual projects.
Oversee the Statistical team to ensure delivery of high-quality outputs on time and in-line with customer expectations to achieve a high level of customer satisfaction.
Participate in data focused project team meetings, meeting frequently with the project team to ensure that all deliverables are planned and coordinated within the project team.
Work with the project team to proactively identify potential risks and put in place mitigation and contingency plans.
Effectively communicate any data and scientific driven discussions to achieve project deliverables on time and to high quality.
In addition, specific responsibilities will include:
Serve as the Project Statistician for allocated projects.
Be responsible and accountable for all statistical deliverables per the established timeline.
Provide leadership to the Statistical project team and provide instruction to deliver the project objectives.
Review the project team’s output regularly to ensure the highest quality deliverables.
Review and, where necessary, adjust the resource allocation within the Biostatics department to ensure that the Biostatistics project portfolio can be delivered effectively, on time, within budget and to a high quality.
Ensure that all relevant protocols, project plans, SOP’s and regulatory requirements are adhered to.
Develop timelines with the Project Manager for all statistical deliverables, in line with the project contract and project/business objectives.
Communicate risks and issues effectively to the project team and provide regular updates to the project team.
Ensure that all statistical documentation is generated in a timely fashion in accordance with SOP and project timelines.
Maintain complete and accurate records for all statistical activities.
Generate, review and provide input into project plans and documentation e.g. Protocol, Data Management Plan, Statistical Analysis Plan, Clinical Study Report
Develop and drive best working practices and process improvement. Input in writing, reviewing and updated departmental SOPs and associated forms and templates.
Provide input into study design, sample size calculations and patient randomization schemes.
Provide input and review statistical aspects of case report form design.
Prepare Statistical Analysis Plans.
Perform Statistical analyses.
Interpret study data and report results.
Prepare or review the statistical methods sections of the Clinical Study reports.
Perform QC of all statistical deliverables.
Attend and provide input to internal, client or regulatory audits or inspections.
PhD or MSc in biostatistics or related discipline.
Considerable demonstrable experience in Biostatistics and in-depth working knowledge of effective statistical practices. Preferably, a minimum of 5 years in a Statistician role within the Pharmaceutical or CRO Industries.
Strong analytical and data interpretation skills.
Excellent computer skills including expert use of statistical analysis using SAS.
In-depth working knowledge of applied parametric and nonparametric statistics and statistical programming skills.
Excellent oral and written communicative skills. Fluent in oral and written English.
Excellent time management to organise and prioritise workload.
Ability to lead by example on process development, departmental and project objectives, and overall business strategy and initiatives.
Ability to work in a collaborative team environment.
Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise. Encourage team members to apply the same approach to seek solutions.
Knowledge of drug development process including the relationship between the CRO industry and Pharmaceutical companies.
Knowledge of the regulatory framework that surrounds drug development and the clinical trial process.
Knowledge of clinical trial process; including the interaction between the Statistical team with the wider Biometrics team and clinical operations.
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please note that if we receive a high volume of applications this date may be brought forwards.
Salary: Competitive + Negotiable £ Apply Now