Statistician - Netherlands
Want to know company name or location? Company managed [?]
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?
- 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