This job is currently Archived,
Posted on : 30 March 2017
What we offer!
- We offer an exciting and innovative working environment within a very committed start-up organization, great colleagues and a lot of fun!
- We believe in our strong culture; personal responsibility, flexible work hours and places.
- Off course we pay a good salary.
- You will have a training budget and we will pay your pension and you will get travel allowance.
- Do you think you can contribute in achieving our mission
- Do you want to work in challenging environment where your work can really make a difference?
What are you going to do:
This position will report to the Vice President, Head of Clinical Research Development. Operating independently, under the broad guidance of the VP, the statistician will be primarily responsible for the following:
- Will serve as lead Statistician on complex trials across multiple rare disease/orphan programs
- Work with the clinical development teams on innovative study design, and the development of clinical study protocols
- Develops statistical analysis plans, including the definitions of derived variables, the structure and content of analysis data-sets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports
- Guide and collaborate with Contract Research Organizations to ensure alignment with established data, analysis and quality standards
- Ensures that Case Report Forms (CRFs) efficiently capture required trial data and are consistent with data standards
- Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs to improve quality, efficiency and timeliness of work processes
- Represent our company as a Subject Matter Expert for statistical analysis including submission meetings with regulatory authorities
- Review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
- Provide statistical input in the design and review of nonclinical experiments (protocol, reports)
- Excellent verbal and written communication skills are required
- Good interpersonal are essential
- Advanced degree preferred, Ph.D. or M.S. in statistics, biostatistics, or related field
Experience and Skills:
- 7+ years experience as a clinical development statistician in the biotech/pharmaceutical/CRO industry
- Experience in the design, planning and evaluation of clinical trials in orphan/rare disease diseases (preferred)
- Excellent knowledge of SAS programming and associated areas and their application to the biotech industry, particularly as it applies to clinical trial data, and regulatory submission experience
- Experience working with translational data highly preferred
- Experience in a drug development is required
- Knowledge of Bayesian and Frequentist methods preferred
- Excellent technical writing skills; experienced in SOPs, protocols, reports highly preferred
- Experience with Quality Systems, cGMP, and ICH Requirements preferred
- Ability to analyze data, write reports and interpret data
- Knowledge of statistical concepts and techniques, including modeling
- Ability to prioritize and effectively manage several projects simultaneously
- Meet project deliverables and timelines from a statistical perspective
- Work collaboratively within a multidisciplinary team
- Good organization, time management and attention to detail skills needed to work under tight deadlines while maintaining focus on details and quality
- Applies good judgment and leads problem solving within the team
- Experience in the development of Integrated Summaries of Safety and Efficacy Analyses
- Deep Knowledge of CDISC SDTM and ADaM models and experiences in transforming raw data into those standards
- Knowledge of Spotfire or other data analysis visualization tool (preferred)
- English language: fluent; Dutch speaking not required
2333 CK Leiden The Netherlands
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