Provides technical leadership, knowledge, experience and expertise by planning and executing the statistics analysis function in a highly regulated medical diagnostics business. Works as a member of the Clinical and Regulatory affairs department, for the development of statistical methodologies, application tools/programs, and protocols/analyses/reports, for product development and manufacturing release to customers. Prepares written reports and other technical documents and procedures pertaining to statistical methods. Provides statistical consulting and training.
- Applies extensive fundamental and specialized knowledge to the development of protocols, responding to FDA questions, implementing new approaches to automated data processing for clinical trials
- Provides statistical and data analysis support to R&D and regulatory teams developing MDx IVD assays and systems
- Proposes new ideas and recommends implementation plans leading to enhanced efficiencies and faster review and analysis of data
- Coordinates and interacts with technical experts within the organization or external experts, as required.
- Designs and leads designing, planning and executing complex research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products
- Designs and leads the preparation of statistical components of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards
- Leads the analysis, evaluation and planning for methods of approach, and organizes means to achieve the solution to highly complex problems
- Interprets and evaluates statistical data and results of the most complex investigation and develops appropriate recommendations
- Designs and leads the testing or investigations pertaining to the development of the most complex new designs, methods, materials, or processes and investigates possible application of results
- Leads the development of reports, charts, graphs, and other documents and makes recommendations.
- Reviews and approves related inputs such as statistical analysis and specifications prepared by technical support personnel
- Leads the delivery of specifications and may individually deliver programs and analysis to support clinical submissions
- May lead the development of standards for clinical conduct, data collection, management and/or reporting
- PhD or MS degree preferably with two or more experience years within an IVD-MDx business
- Two or more years of experience with FDA regulated clinical trials highly desirable
- Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solutions to novel problems
- Sound knowledge of statistical methodologies such as analysis of variance, regression, experimental designs, contingency tables
- Familiarity with usual statistics tools as SAS, R and Python
- Familiarity with OTS commercial statistical packages applied to a regulated medical business
- Ability to work independently and in project teams
- Fluency in written and spoken English is essential. Any other European language is an advantage
The position will be based in Luxembourg.
If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary, by post or email to the following address:
Fast Track Diagnostics S.à.r.l.
Ms. Elisabeth CHACTOURA
29, rue Henri Koch- L-4354/ Esch s/ Alzette