A specialist contract research organisation (CRO) are looking to hire multiple Principal Statisticians to work out of their UK offices. The organisation provides high quality analysis and consultancy of Phase I-IV clinical trials across a variety of therapeutic areas for the pharmaceutical industry. This position offers the exciting opportunity to work with a leading establishment and provider of real expertise in the biometrics field. You would be joining a team that is looking to invest in long term careers, focusing on quality of service, with up to date, relevant industry training.
- Perform technical review and provide input into clinical trial documents including protocols, CRFs, and CSRs.
- Author and review study SAP, TFL shells, and dataset specifications.
- Support study and/or compound level activities, advising on study design and statistical issues across phases and therapeutic areas.
- Author, validate, and document SAS programs for datasets, TFLs, and macros, applying good programming practice.
- Apply complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking, and interpretation.
- Identify and implement appropriate sample size method using software or simulations.
- Identify data and standards issues and resolve or escalate as appropriate.
- Maintain proficiency in statistical methodology.
- Maintain study master file documents and any other documents that are required to be audit ready.
- Line manage statisticians, programmers and other technical staff.
- Be accountable for overall performance of direct reports.
- Provide coaching and mentoring of staff to achieve "excellence".
- Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs.
- Interview and effectively on-board and integrate new staff members.
- Provide statistical technical leadership and coaching.
- Oversee key client projects/portfolios, including:
- Project Manage client accounts and projects
- Maintain the project plan
- Proactively manage resource, scope change, and risks
- Manage the delivery of projects to budget
- Manage client expectations and issue resolutions
- Lead internal and client study, project, and cross functional team meetings effectively.
- Present study updates internally and at client meetings.
- Share scientific, technical, and practical knowledge within the team and with colleagues.
- Perform work in full compliance with applicable internal and client policies, procedures, processes, and training.
- Build effective collaborative working relationships with internal and client team members.
- Ensure learnings are shared across projects or studies.
- Develop and provide internal technical training where appropriate.
- Lead process improvement initiatives.
Skills and Requirements:
- Typically requires a BSc in a relevant scientific discipline.
- Typically requires relevant clinical experience in the pharmaceutical or health care industry or equivalent.
- Previous experience in the management of Phase IV and Non-Interventional studies is essential.
- Experience in the review and oversight of Investigator Sponsored Trials desirable.
- Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.
- Must be able to generally understand, interpret, and explain protocol requirements to others.
- Good knowledge and understanding of ICH GCP, GVP, FDA, and EMEA regulations and guidelines applicable to post-authorization studies.
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.