ProClinical are recruiting on behalf of a leading contract research organisation who have a vacancy for a Senior/Lead Statistical Programmer. In this job, you will be working at a company that is at the forefront of drug development and has helped to commercialise many leading therapies. This role can be based in Germany or the Netherlands. The Senior / Lead Biostatistician role will provide experienced technical expertise to develop process methodology for department to meet internal and external clients' needs. This is a permanent role, based in Strasbourg, France.
- Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically.
- Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
- Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
- Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies.
- Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
- Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
- Use and promote the use of established standards, SOP and best practices.
- Provide training and mentoring to SP team members and Statistical Programming department staff.
Skills and Requirements:
- Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries
- Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of statistics, programming and/or clinical drug development process
- Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
- Good organizational, interpersonal, leadership and communication skills
- Ability to independently manage multiple tasks and projects
- Ability to delegate work to other members of the SP team
- Excellent accuracy and attention to detail
- Ability to delegate work to other members of the SP team [SPM]
- Exhibits routine and occasionally complex problem-solving skills
- Recognizes when negotiating skills are needed and seeks assistance
- Ability to lead teams and projects and capable of managing at a group level
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Master’s degree in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 5 years relevant experience; or equivalent combination of education, training and experience
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 call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.