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The Role CSL is looking for a Principal Programmer to take technical ownership of statistical programming across a compound or programme, not just a single study. You’ll be the person who sets how the programming gets done across multiple trials and through to submission, and the one a study team, a CRO or a regulator’s question ultimately lands with. This is still a hands-on role, and you’ll write and validate code when the work calls for it. Most of your impact, though, comes from the decisions upstream: how standards are applied across studies so an integrated analysis comes together cleanly, how CRO work is scoped and held to account, and how a submission package is built so it holds up under review. You’ll work as a peer to biostatistics, data management, medical writing and regulatory leads, and you’ll be in the room early enough to shape a programme’s analysis strategy rather than inherit it. Hybrid Based (3 days a week onsite) in Maidenhead Why It Matters A single well-programmed study is valuable. A programme where every study was built to the same standard, so pooled safety and efficacy analyses come together without months of rework, is what gets a submission over the line. This role sits at that level. You spot the inconsistency between two studies’ ADaM conventions before it becomes an ISS problem, push back on a CRO deliverable that technically meets spec but won’t survive a reviewer, and make the call on the trade-offs between speed, consistency and regulatory defensibility. When an agency query comes back, you’re the one who knows why the data was built the way it was. What You’ll Be Responsible For You’ll lead programming at the programme or compound level, across in-house and outsourced studies, from study setup through integrated analyses and regulatory submission. You’ll set direction for other programmers, internal and external, and help shape how the wider programming function works. • Serve as lead programmer for a compound or programme, overseeing programming across multiple clinical trials and ensuring consistency of standards and approach, • Lead the planning, specification and delivery of integrated analyses (ISS/ISE) and pooled datasets, and own the submission-ready data package, including define.xml, reviewer guides (cSDRG/ADRG) and conformance checks, • Define programming strategy for outsourced studies, set expectations for CROs and hold their deliverables to submission standard, • Act as the programming point of contact for regulatory submissions and agency queries, working with biostatistics and regulatory colleagues on responses, • Lead and mentor other programmers, providing technical direction, review and day-to-day guidance across the programme, • Contribute to departmental standards, macros, tools and process improvement, including the adoption of new approaches such as R-based workflows, • Take on hands-on programming and ad hoc analytical work (exploratory analyses, publication support, regulatory responses) as the programme requires Experience Required • Substantial statistical programming experience in pharmaceutical, biotech, CRO or clinical research settings, including lead programmer responsibility across multiple studies, • Expert SAS proficiency (Base/Macro/Stat/Graph); working experience with R or other languages is a strong plus, • Deep, practical knowledge of current CDISC standards (CDASH, SDTM, ADaM, define.xml) and how to apply them consistently across a programme, • Track record of leading integrated analyses (ISS/ISE) and delivering submission-ready data packages, • Direct experience of supporting regulatory submissions end to end (FDA required; PMDA, NMPA or EMA experience a plus), including responding to agency queries, • Experience of setting direction for and overseeing CRO and vendor programming work, • Experience of leading, mentoring or technically directing other programmers, • BSc in Computer Science, Mathematics, Statistics or a related field (MSc desirable); equivalent experience and certifications will also be considered

Global Regulatory Strategy (GRS) CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong focus on collaboration, we’re building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing therapies that make a meaningful difference for patients around the world. The Director, Senior Global Regulatory Lead (Sr. GRL) is a key member of CSL’s Global Regulatory Strategy (GRS) organization and serves as the global regulatory leader for assigned products within the respective therapeutic area. In this highly visible, strategic role, you will develop and lead innovative, science-driven global regulatory strategies across the product lifecycle, from early development through registration and post-marketing activities. You will serve as the primary Global Regulatory Affairs (GRA) representative on Product Strategy Teams (PSTs) and other cross-functional development teams, ensuring regulatory strategies are integrated into product development decisions and aligned with broader business objectives. As a trusted regulatory partner, you will build and maintain productive relationships with global health authorities, particularly the FDA and EMA, while guiding regulatory teams through complex development and approval pathways. You will influence strategic decisions, anticipate regulatory challenges, and identify opportunities to accelerate the delivery of innovative therapies to patients. Depending on the role, you may also lead and develop Regional Regulatory Leads, fostering a collaborative, accountable, and high-performing global team. • Develop Global Regulatory Strategy: Establish and lead integrated, science-based global regulatory strategies for assigned products, supporting development, registration, and post-marketing lifecycle activities while balancing innovation, patient needs, and business priorities., • Lead Cross-Functional Regulatory Partnership: Serve as the primary GRA representative on Product Strategy Teams and partner with Clinical Development, Safety, Commercial, Research, and other key stakeholders to ensure regulatory considerations are incorporated into product strategy and decision-making., • Drive Health Authority Engagement: Lead strategic relationships and interactions with key health authorities, including the FDA and EMA, and collaborate with regional regulatory partners to support successful regulatory outcomes across global markets., • Provide Regulatory Leadership and Oversight: Lead the Global Regulatory Affairs Strategy Team (GRAST) for assigned products, establishing priorities, coordinating deliverables, assigning responsibilities, and ensuring alignment across global regulatory functions., • Influence Product Development Decisions: Serve as the primary GRA reviewer and, where appropriate, approver of key development deliverables, including protocols, Target Product Profiles (TPPs), and other strategic documents. Provide regulatory guidance to senior leadership and cross-functional teams., • Lead Strategic Regulatory Deliverables: Oversee the development of key regulatory documents and initiatives, including Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans, and Global Regulatory Strategy Outlines., • Drive Regulatory Intelligence and Innovation: Leverage competitive regulatory intelligence, emerging technologies, AI-enabled insights, business analytics, and specialized regulatory expertise to inform strategy, assess opportunities, and proactively address potential challenges., • Promote Global Regulatory Alignment: Build strong relationships across Global Regulatory Strategy, including regional regulatory teams and Regulatory CMC, to promote consistency, knowledge sharing, and a unified global regulatory approach., • Lead and Develop Talent (where applicable): Coach and develop Regional Regulatory Leads, establish clear performance expectations, foster accountability, and support succession planning and career growth., • Champion CSL Leadership Capabilities: Demonstrate CSL’s leadership capabilities by building partnerships, thinking strategically, driving outcomes, embracing agility, inspiring innovation, and cultivating talent. Education • Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science discipline required., • Advanced degree (MS, PhD, MD, DVM) or MBA preferred. Experience • Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, including at least 8 years in Regulatory Affairs., • At least 5 years of experience supporting pharmaceutical or biological product development., • Demonstrated experience leading teams, preferably with 5 years of direct or matrix leadership experience, including setting strategic direction, driving accountability, and developing talent., • Strong knowledge of pharmaceutical and biological product development and regulatory requirements across multiple major regions, including the US, EU, and/or Japan., • Demonstrated experience working directly with at least one major health authority, such as the FDA or EMA., • Experience navigating complex, global, matrixed organizations and influencing cross-functional stakeholders., • Strong clinical development or medical device expertise is highly desirable. The successful candidate will bring: • Strong strategic thinking and the ability to translate complex regulatory considerations into actionable development strategies., • Excellent communication, influencing, and relationship-building skills, including the ability to engage effectively with senior leadership and health authorities., • Sound judgment and confidence in making complex regulatory decisions and taking calculated risks., • The ability to lead through influence, foster collaboration, and drive accountability across geographically dispersed teams., • A patient-focused mindset and passion for advancing innovative therapies through successful development and approval. The expected base salary range for this position at hiring is $242,000 - $270,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. #LI-HYBRID #J-18808-Ljbffr