Veramed is a specialist contract research organisation (CRO) to the pharmaceutical industry, focused on delivering high quality statistics and programming for the reporting of Phase I-IV clinical trials across a variety of therapeutic areas. The projects and clients we work with provide a varied and exciting challenge; this in turn enables us to help develop and enhance our employees’ capabilities and gives opportunities for growth.
The role of the Consultant Statistician is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas.
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
- Perform technical review and provide input into clinical trial documents including protocols, CRFs, 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.
- Application of 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.
- Awareness of emerging standards and associated impact to ongoing and future planned trials.
- Maintain proficiency in statistical methodology.
- Maintain study master file documents and any other documents that are required to be audit ready.
- Oversight of key client projects/portfolios, including:
o Being Lead Statistician on client accounts and projects (where necessary).
o Managing client expectations and issue resolution.
- Input into and review of project management documents.
- Contribute to internal and client study team meetings.
- Perform work in full compliance with applicable internal and client policies, procedures, processes and training.
MINIMUM QUALIFICATION REQUIREMENTS:
- BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience).
- At least 6 years of relevant industry experience.
- Awareness of industry and project standards & ICH guidelines.
- Excellent verbal and written communication skills.
- Interpersonal/teamwork skills for effective interactions.
- Proficiency in data handling using SAS or other statistical software (e.g. R).
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
- Ability to work independently and as part of a team.
If you wish to apply for this role please follow the steps below to register with Veramed Recruitment, and upload your CV and cover letter for review. You must complete both steps of this process to complete your application.