Sr. Principal Analyst, Statistical Programming

📋 Description

• • As a Senior Principal Analyst, Statistical Programming at Biogen, you will be at the forefront of ensuring the quality and integrity of statistical programming activities crucial for drug development and regulatory submissions.
• • You will lead and oversee a critical function within the organization, managing both internal statistical programming teams and external vendors to deliver high-quality, submission-ready outputs.
• • Your role involves a deep dive into data standards, the meticulous production of analysis datasets, and the creation of comprehensive analysis dataset specifications, ensuring adherence to industry best practices.
• • You will be instrumental in generating tables, listings, and figures, as well as preparing essential electronic submission components, including define.xml and XPT files, working closely with Biostatistics to achieve these goals.
• • A key responsibility is partnering with Biostatistics to ensure that all statistical outputs are not only accurate but also fully compliant and ready for regulatory review.
• • You will play a pivotal role in strategic planning, providing essential input to the Statistical Programming Portfolio Lead (PL) regarding overall study timelines, resource allocation, and the monitoring of program milestones.
• • Proactive issue identification and escalation will be a core part of your duties, ensuring that potential roadblocks are addressed swiftly and effectively in collaboration with your counterparts.
• • You will be responsible for estimating resource needs, ensuring that the statistical programming team is adequately staffed and equipped to meet project demands.
• • Leading a drug program team of statistical programmers, you will guide them in accomplishing complex tasks, fostering a collaborative and high-performing environment.
• • Effective communication of issues and progress to senior management will be vital, ensuring transparency and alignment across the organization.
• • A significant aspect of your role will involve the communication and quality oversight of vendor performance, ensuring that external partners meet Biogen's stringent quality standards.
• • You will confidently represent the Statistical Programming perspective in study teams and Clinical Development Teams, often serving as the sole functional representative, demonstrating your expertise and leadership.
• • You will actively contribute to the implementation of the Data and Programming Strategy, influencing the strategic direction of programs.
• • Providing input to Data Standards personnel and Data Management (DM) on the strategic direction of programs will be essential for maintaining consistency and efficiency.
• • You will partner with the PL to guarantee the appropriate implementation of statistical programming standards across projects.
• • Serving as a key reference point for Data Standards personnel, you will provide guidance and support to ensure adherence to established standards.
• • You will develop and implement standard programming practices, ensuring their consistent application across studies and programs.
• • Collaboration on tools and process improvements for Statistical Programming is encouraged, driving innovation and efficiency within the department.
• • You will author CDISC ADaM (Analysis Data Model) analysis data set specifications, demonstrating a deep understanding of data modeling for clinical trials.
• • Identifying potential data issues or areas requiring critical data examination will be part of your analytical responsibilities.
• • You will work closely with statisticians to define and document programming endpoint algorithms, contributing to the development of robust analytical methodologies.
• • Your responsibilities extend to managing the end-to-end programming of deliverables, from CRF collection through to electronic submission.
• • This includes the preparation of electronic submission (ESUB) components, such as reviewer's guides, annotated CRFs, define files, and XPTs, ensuring compliance with eSUB standards.
• • You will proactively identify process inefficiencies and lead initiatives to implement improvements, training the department on new methodologies.
• • Serving as the Statistical Programming Lead, you will be accountable for achieving milestones for drug programs, evaluating task objectives, and collaborating on resource needs.
• • You will verify program consistency and the correct usage of data, analysis, and submission standards across the department, in consultation with relevant teams.
• • Keeping internal and external project team members informed about statistical programming requirements, deliverable status, and resource needs is a crucial communication function.
• • You will be a recognized statistical programming expert within the department, mentoring and guiding other programmers.
• • Your role is pivotal in ensuring the successful progression of clinical trials from data collection to regulatory submission, impacting patient access to life-changing medicines.