Job Title: Director, Statistical and Data Management Programming
About the Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused
exclusively on development and manufacturing of high-quality biosimilar
medicines.
Within Research and Development (R&D;) function, the integrated Clinical and
Medical Research (iCMR) department develops effective strategies aligned with
biosimilar guidelines and health authority requirements to deliver successful
clinical studies, and support post marketing-authorization related activities.
iCMR is launching an ambitious and exciting project aimed at modernizing
and optimizing the departmental operating model. As part of this project, we are
recruiting for the following position:
Overview of Job Role
The Director of Statistical and Data Management Programming will be responsible
for establishing, leading and advancing statistical programming and Data
Management (DM) programming activities for biosimilar studies, ensuring
high-quality and timely deliverables. They will provide strategic leadership and
support the vision of both Statistical and DM programming functions through the
establishment of robust programming capabilities, processes, standards, and
quality frameworks. In addition, this role requires a hands-on approach,
particularly during the build-out and maturation of the function, with direct
involvement in programming activities, deliverable development, process
implementation, and technical oversight.
Scope and responsibility
* Develop and guide the strategy for programming activities, ensuring adherence
to standards and processes.
* Serve as functional expert and senior advisor for data standards, programming
methodologies, and submission strategies.
* Contribute to developing and updating company-wide Standard Operating
Procedures (SOPs) for DM and statistical programming.
* Establish and maintain programming standards, validation procedures, and
reusable code libraries.