Director, Statistical Programming
职位标题：总监，统计和数据管理部门/公司关于项目 Alvotech 是一个完全集成的专业生物制药公司，专门关注高质量的仿生药物开发和生产。在研发 (R&D) 功能中，综合临床和医学研究 (iCMR) 部制定了与仿生指导方针和卫生当局要求一致的有效战略，以提供成功的临床研究，并支持营销授权后相关活动。iCMRis 启动了一个雄心勃勃的项目，旨在现代化和优化部门运营模式。作为本项目的一部分，我们正在招聘以下职位：JobRole 概述 统计和数据管理编程主任将负责建立，领导和推进生物类似研究的统计编程与数据管理 (DM) 项目活动，确保高质量及时交付。他们将提供战略领导力并通过建立强大的编程能力，流程，标准和质量框架来支持统计和 DM 编程功能的愿景。此外，这一角色需要实践方法，特别是在该职能的构建和成熟过程中，直接参与编程活动，可交付开发，进程实施和技术监督。范围和责任 ·制定并指导编程活动的战略，确保遵守标准和流程。·作为数据标准，编程方法及提交策略的功能专家和高级顾问。·为公司范围内开发和更新 DM 与统计程序的标准操作程序 (SOP). ·建立和维护编程标准，验证程序和可重复使用代码库。·通过标准化，自动化和创新的编程解决方案提高效率。·与生物统计学，DM 和其他临床研究团队合作，协调分析和报告产品交付。·与 DM 合作，开发和验证编程代码以支持数据清理差异和调整输出。·执行并监督 SDTM 和 ADaMdatasets 的编程，表格，列表，图像 (TLF) 和准备提交包 （包括注释案例报告表格，Pinnacle21检查，Defin.xml 和审查者指南）. ·确保规范。
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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