Director, Statistical Programming
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.
Drive efficiency through standardization, automation, and innovative programming solutions.
Partner with Biostatistics, DM, and other clinical study teams to align analysis and reporting deliverables.
Develop and validate programming code to support data cleaning discrepancies and reconciliation outputs, in collaboration with DM
Perform and oversee programming of SDTM and ADaM datasets, Tables, Listings, Figures (TLFs), and submission-ready packages (including annotated Case Report Form, Pinnacle21 checks, Define.xml and Reviewers guides).
Ensure regulatory compliance with ICH-GCP, CDISC standards, FDA, EMA, and other global regulatory requirements.
Maintain inspection and audit readiness.
Coach, mentor, and develop direct reports, ensuring training compliance and participating in the hiring process.
Support resource forecasts to optimize project allocation and manage resource utilization effectively.
Job requirements
Master’s degree or equivalent with 15+ years of relevant experience.
10+ years of experience in Statistical Programming within the pharmaceutical industry including leadership and people management responsibilities.
Extensive experience in the life sciences sector with a strong understanding of drug development processes.
Deep knowledge of regulatory requirements related to statistical programming, validation, and data governance.
Expert-level understanding and practical knowledge of CDASH, SDTM, ADaM, and CDISC controlled Terminology standards.
Advanced expertise in SAS programming (proficiency in other language is a plus), relational database structures, and data workflow.
Experience supporting global regulatory submissions (FDA, EMA, PMDA).
Excellent project management skills and ability to handle multiple projects simultaneously.
Able to work in cross-functional and international team.
Strong leadership, communication, and interpersonal skills.
Full working proficiency in English.