Director, Statistical Programming

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