Senior Manager, Biostatistics (RWD/RWE)

📋 Description

• • As a Senior Manager, Biostatistics with a focus on Real-World Data (RWD) and Real-World Evidence (RWE) at BeiGene, Ltd., you will play a pivotal role in shaping and executing advanced statistical analyses that drive critical insights into cancer treatment and patient outcomes.
• • This position offers a unique opportunity to contribute to the fight against cancer by leveraging cutting-edge methodologies and large-scale datasets to inform strategic decision-making across clinical development and commercial operations.
• • You will be instrumental in designing, planning, and leading sophisticated statistical analyses for a variety of RWD/RWE studies. This includes, but is not limited to, comparative effectiveness research, safety assessments, observational studies, the development of external control arms, and comprehensive outcomes research.
• • A key aspect of your role will involve overseeing and rigorously validating all statistical programming deliverables. This ensures that the analyses conducted are not only accurate and reproducible but also strictly adhere to study objectives, regulatory requirements, and the highest publication standards.
• • You will actively perform statistical programming, utilizing a range of relevant programming languages within a big data environment. This hands-on work is crucial for data extraction, conducting complex analyses, validating results, and generating comprehensive study reports.
• • Embracing innovation, you will apply Artificial Intelligence (AI) capabilities to significantly enhance data preparation processes, optimize code development, improve analytical efficiency, and automate workflows, thereby streamlining research operations.
• • You will be responsible for developing individual protocols and Statistical Analysis Plans (SAPs), meticulously determining the most appropriate statistical methodologies for RWD/RWE studies to ensure scientific rigor and validity.
• • Your expertise will be applied to analyzing vast and diverse datasets sourced from various origins, including claims databases, Electronic Health Records (EHRs), patient registries, and patient-reported outcomes, providing a holistic view of treatment impact.
• • You will actively participate in database design meetings, ensuring that the data collected is of the highest quality and precisely meets the analytical requirements of the studies.
• • Close collaboration with statistical programming staff is essential to guarantee that all programs meet both internal analysis needs and external regulatory and publication requirements.
• • You will perform the key and often innovative components of the statistical analyses and provide insightful interpretations of the results, translating complex data into actionable intelligence.
• • The role requires you to prepare clear, concise, and effective oral and written reports to communicate study findings to a variety of stakeholders, including scientific peers, regulatory bodies, and internal teams.
• • You will be involved in the review of statistical documents throughout the project lifecycle – from initiation and conduct to reporting – particularly when external vendors are engaged, ensuring consistency and quality.
• • A significant part of your contribution will involve engaging in research activities focused on developing and applying innovative statistical methods and their practical applications within clinical trial development and RWE generation.
• • You will be expected to prepare materials and conduct training sessions for both internal and external audiences, particularly for initiatives driven by Medical Affairs (MA) and commercial teams, disseminating knowledge and best practices.
• • Furthermore, you will provide expert statistical consultation and review services to other functions within the organization, such as clinical development and commercial teams, offering critical statistical guidance on their projects and initiatives.
• • This role demands a proactive and detail-oriented approach, with a consistent focus on execution and a strong ability to learn and adapt in a dynamic research environment.
• • You will thrive in a team-oriented setting, effectively collaborating with cross-functional team members to achieve shared research and business objectives.
• • The position is remote within the US, offering flexibility while requiring travel as dictated by business needs.