Abbott Head Global Statistics in Weesp, Netherlands
The Established Pharmaceuticals Division (EPD) of Abbott is looking:
Head Global Statistics
About the team
The direct team is a group of Statisticians supported by Clinical Data Operations Managers and Data Specialist. The group is expected to grow in the next years.
Together they are responsible for the design and analysis of clinical studies from Phase 1 to 4 as well as observational and Real World studies in patients and the oversight of the CRO contracted for the operations. The regulatory setting is exciting to design clinical studies for BRIC countries with rapidly evolving regulatory requirements as well as global international studies that meet typical ICH Regions demands. Another new dimension to the group is the conduct of Real World studies and digital studies requiring novel statistical approaches.
The Head Statistics will lead the Global Statistics department. Furthermore he/she assures and provides the availability of statistical methodology in all therapeutic areas within the EPD. The Head Statistics contributes to internal scientific review and approval board. In this role it is important to manage and govern approval process of statistical deliverables.
Tasks and responsibilities
Manages the statistic team and provides leadership to Statistics within the EPD.
Mentor/coach and support the education and training of Statistics staff in the technical arena in Global group as well as in the Regions.
Accountable for all technical statistical contributions to Clinical Development and Medical Affairs.
Oversees adequate and qualified support to the projects concerning Statistics in cooperation with CRO(s).
Oversees the statistical and methodological contributions to support the Project Teams.
Accountable for successful and timely completion of statistical contributions as part of project milestones that directly impact the business through timely and adequate submissions and product support.
Supports and develops the utilization of the data to enhance the knowledge and profiling of the compounds (e.g., integrated individual patient data analyses, meta-analyses and statistics explorations).
Engages in the design and analysis of observational studies, and Real World data studies, including the use of medical devices/wearable’s/sensors that will bring new data streams and will require novel statistical approaches.
Collaborating with representatives from various scientific and operational functions to ensure success of projects teams.
Develops relationships with international opinion leaders, consultants and collaborative groups.
Background and competences
Master or PhD in the field of Mathematics, Bio-informatics or equivalent;
Expertise in high quality statistical study designs in drug/clinical development and experience in regulatory interactions;
5 years relevant work experience in a manager position;
Interest in Real World Evidence and digital studies, including e.g., Machine Learning;
Strong communication skills and open personality;
Good organization and project management skills;
Can do mentality;
Willing to travel abroad a few times a year;
Excellent writing and speaking skills in English.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com