Director, Statistical Programming

🕒 October 16

🇸🇪 Sweden – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 15%

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Alvotech

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $78.3M Post IPO equity on 2025-07

Biotechnology • Pharmaceuticals • Healthcare

Alvotech is a biopharmaceutical company that specializes in developing and manufacturing biosimilars—biologic medicines highly similar to approved reference biologics—to increase global patient access to affordable biologic therapies. The company follows a vertically integrated approach, covering cell line development through fill-and-finish manufacturing, and partners with commercialization experts to bring products to market. Its pipeline includes proposed biosimilars to high-profile biologics, and it emphasizes scale, control and speed in production. Alvotech operates globally and focuses on improving access to biologic medicines.

📋 Description

• 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 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 Forms, 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

🎯 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 languages is a plus • Knowledge of relational database structures and data workflows • Experience supporting global regulatory submissions to FDA, EMA, and PMDA • Excellent project management skills and ability to handle multiple projects simultaneously • Ability to work in cross-functional and international teams • Strong leadership, communication, and interpersonal skills • Full working proficiency in English

🏖️ Benefits

• Fully remote work arrangement

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