Beschreibung
You are a Expert in Statistician?You are a Expert in Statistician?
I am currently looking for a Freelancer Senior Statistician for a well-known Client in Germany 100 % Home-office .
Please find below what our client requests:
Main Duties and Responsibilities
- Provides expert consultation and advice in quantitative/statistical, experimental design, and data management issues. Works with the clinical monitor and cluster team to develop clinical protocols, analysis plans and final study reports for clinical development projects. Plans, coordinates, and produces statistical analyses and summaries in support of product development.
- Member of core clinical cluster team, attend meetings as and coordinates activities for assigned clinical trials with internal data management and programming staff, medical writing and regulatory affairs.
- Ensure that clinical development projects meets scientific, regulatory, quality, and commercialization requirements
- Plan and track project level activities for B&SR.
- Support submission activities, like ISS, ISE, briefing books.
- Interact with Clinical Data Management as appropriate.
- Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings.
- Maintain records for all assigned projects and archive trial / project analysis and associated documentation.
- Coach and mentor cluster Statistician(s)
Experience and Knowledge
Essential Skills
- Demonstrated sound knowledge of statistical applications.
- Awareness of appropriate regulations and guidance documents.
- Preferably SAS programming knowledge and Vaccine knowledge
- Some Medical knowledge, especially in relation to specific vaccines area.
- Strong problem solving skills and sound statistical judgment. Technical capability to address common statistical problems arising in work.
- Attentiveness to detail.
- Strong interpersonal skills. Effective oral & written communication skills.
- Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
- Demonstrated ability to complete complex tasks on a timely basis with minimal supervision; well organized.
- Good project management skills.
- Good team player, good business ethics
Key Competences
- Strong analytical and communicational skills
Qualifications
Education in mathematics, statistics, computer science, life sciences or other related field.
Ph.D. in statistics, biostatistics or mathematics with at least 2 years directly related experience (pharmaceutical industry preferred), or Masters Degree. in statistics, biostatistics or related area with at least 4 years directly experience in pharmaceutical industry.
Language Skills
Very good in English
Framework Condition:
Start Date: asap
Duration: 12 Months, 100 % Home-office
Are you interested?
I am looking forward to receive your CV via email to
Jelena Stupar - Consultant Clinical Data Management and Biostatistics - j.stupar[at]progressiverecruitment.com - .
Please feel free to forward my job descriptions to people within your network.