Director, Statistical Programming
About this role
Job Title:Director,Statisticaland Data ManagementProgramming
AbouttheDepartment/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively ondevelopmentand 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.
iCMRis launching an ambitious and exciting project aimed at modernizing andoptimizingthe departmental operating model. As part of this project, we are recruiting for the following position:
Overview ofJobRole
TheDirector ofStatisticaland Data ManagementProgrammingwillberesponsible forestablishing,leadingand advancing statistical programmingandData Management (DM)programmingactivitiesforbiosimilarstudies,ensuring high-quality andtimelydeliverables.They will provide strategic leadership and support the vision of both Statistical andDMprogrammingfunctionsthrough 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.
Scopeandresponsibility
Develop and guide the strategy for programming activities, ensuring adherence to standards and processes.
Serve asfunctionalexpert and senior advisor for data standards, programming methodologies, and submission strategies.
Contribute todevelopingand updatingcompany-wideStandard Operating Procedures (SOPs) forDMandstatisticalprogramming.
Establish andmaintainprogramming standards, validation procedures, and reusable code libraries.
Drive efficiency through standardization, automation, and innovative programming solutions.
Partner with Biostatistics,DM, and otherclinical studyteams to align analysis and reporting deliverables.
Develop andvalidateprogramming code to supportdata cleaningdiscrepanciesand reconciliationoutputs, in collaboration withDM
Perform and overseeprogramming ofSDTM andADaMdatasets, Tables, Listings, Figures (TLFs), and submission-readypackages (includingannotatedCase 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 andparticipatingin the hiring process.
Support resource forecasts tooptimizeproject allocation and manage resourceutilizationeffectively.
Jobrequirements
Master’sdegreeor equivalent with15+ years of relevant experience.
10+years of experience in Statistical Programming within the pharmaceutical industry including leadershipand peoplemanagement responsibilities.
Extensive experience in the life sciences sector with a strong understanding of drug development processes.
Deep knowledge ofregulatory requirementsrelated tostatistical programming, validation, and data governance.
Expert-level understandingand practical knowledgeof CDASH, SDTM,ADaM, and CDISC controlled Terminology standards.
Advancedexpertisein SAS programming(proficiencyin otherlanguageis 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 projectssimultaneously.
Able to work in cross-functionaland internationalteam.
Strong leadership, communication, and interpersonal skills.
Full workingproficiencyin English.
Originally posted on Himalayas