R&D Statistician
Job Information
About the Position
Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Overview
Performs statistics and data management support in accordance with applicable regulations and company policies and procedures, working closely with the R&D team.
The position requires a degree of coordination and communication between the individual and the project team members including vendors. Occasionally interfaces with all levels of the organization.
Responsibilities
Key Accountabilities
- Supports the conduction of all research and development efforts with appropriate statistical planning, maintaining data and analytical integrity.
- Supports statistical aspects of regulatory submissions from design of clinical studies to support 510Ks and PMAs to analysis and reporting of results. Supports the company in meetings with regulatory agencies and prepare oral/written responses to statistical questions raised by regulatory agencies.
- Serves as a statistical analysis subject matter expert for assigned projects.
- Makes recommendations to resolve scientific problems encountered during experimental procedures to improve productivity of results. Ensures activities are consistent with project critical path, and responds appropriately to changing priorities or schedules.
- Collaborates in both in-house and external activities related to statistical programming and to the application of statistics.
- Collaborates with R&D, QC and Manufacturing departments for a continuous improvement system, but also on solving short-term problems.
- Provides statistical analyses in comprehensive written reports or sampling plans, as appropriate.
- Must be able to communicate statistical interpretation, approach and analysis in an understandable manner to people with little or no knowledge of statistics.
Networking / Key Relationships
This position requires cooperation with different company departments but especially with R&D Team, working together with scientists and occasionally managers and Directors.
Qualifications
Minimum Knowledge & Experience Required for the Position
Education
Required:
- Bachelor's degree (Diplomatura) or Master's degree in statistics or related sciences.
- Degree may be substituted by relevant skills and work experience.
Valuable:
- Any additional degree higher than that required in the previous section.
- Knowledge in the biological or related sciences.
Experience
- Four (4) years previous, if not, this statistician experience could be substituted by scientific/in vitro diagnostic research experience.
Additional Skills / Knowledge
- Proficiency in basic software tools (Excel, Word, PowerPoint).
- Knowledge of SAP preferred.
- Proficiency in R statistical programming is required.
- Languages: Fluency in Spanish or Catalan. Advanced knowledge of English (reading, speaking and writing).
Skills & Capabilities
The ideal candidate for this position will exhibit the following skills and competencies:
- Attention to detail and accuracy.
- Able to apply specialized statistical methods and theoretical knowledge to tasks within one area of expertise.
- Good teamwork and interpersonal skills. Ability to interact with other colleagues inside and outside project team.
- Oral and written communication skills.
- Time management skills in order to work on several different projects at the same time and prioritize tasks.
- Good analytical skills.
- Ability to work independently.
- Well organized, able to handle large data sets, and communicate results, problems, and progress to the supervisors, and within the group as required.
- Ability to adapt to R&D flexible and changing environment.
- Technical capacity to review data and reports and documents that are compliant with current company procedures.
- Reflects values of Werfen and Biokit in the quality of work and working relationship.
Travel Requirements
Sporadic travel will be required, not more than 10% of time.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
www.werfen.com
