Senior Director, Statistical Programming

Your mission is to provide strategic and technical leadership for the statistical programming function, driving the delivery of high-quality data and analysis for Bicycle's clinical portfolio. You will ensure operational excellence across all programming activities, serve as a key strategic partner to Biostatistics and Clinical Development, and lead and mentor a team of programmers to support the successful execution of our clinical trials and regulatory submissions. YOUR RESPONSIBILITIES Strategic & Technical Leadership - Provide strategic leadership and hold accountability for all statistical programming deliverables for assigned clinical development programs, ensuring timelines, quality, and compliance are met. - Serve as the senior technical expert on CDISC standards (SDTM, ADaM), programming methodologies, and data submission strategies, guiding the team and vendors on complex implementation challenges. - Partner with the Biometrics Lead to define and execute the long-term vision and strategy for the statistical programming function, including resource planning, technology adoption, and talent development. Operational Excellence & Process Innovation - Drive the strategy for functional excellence by developing, implementing, and optimizing global Standard Operating Procedures (SOPs), tools, and innovative workflows to enhance efficiency and quality. - Oversee the strategic selection and governance of CROs and external vendors, ensuring a harmonized approach to programming and holding partners accountable for high-quality, timely deliverables. - Ensure all statistical programming activities and documentation are inspection-ready, providing senior oversight for data integrity and demonstrable compliance with ICH/GCP guidelines. Team Leadership & Development - You will lead, coach, and mentor your team, investing in their professional growth and fostering a culture of high performance and psychological safety. - You will set clear goals and strategic priorities for your team, ensuring their work is directly aligned with departmental and organisational objectives. - You will champion the Bicycle Values in all that you do, acting as a role model and embedding a culture of collaboration, accountability, and innovation within your team. WHO ARE YOU: SKILLS & COMPETENCIES Knowledge: - You apply expert knowledge of statistical programming and clinical development to set functional strategy and solve complex, multi-faceted problems. You have a deep understanding of the regulatory landscape and its impact on programming deliverables. Job Complexity: - You are accountable for managing a portfolio of complex clinical programs and addressing abstract challenges that require in-depth evaluation of variable factors. You anticipate future needs and develop innovative, long-range solutions for the programming function. Independence: - You operate with a high degree of independence, aligning your team's strategy with broader departmental and company goals. You are trusted to make significant decisions regarding project execution, resource allocation, and vendor management. Values & Behaviours: - You are a role model for the Bicycle Values, leading by example to create an inclusive and high-performing team environment. You build strong, influential relationships with senior stakeholders across the organization and represent the function with credibility. - Demonstrated deep expertise in statistical programming gained through significant and progressive experience in a biotech or pharmaceutical setting. - Proven track record of leading the programming strategy for clinical development programs, preferably within oncology. - Expert-level knowledge of SAS programming and CDISC data standards (SDTM/ADaM), with extensive experience preparing data for regulatory submissions (e.g., NDA/BLA). - Substantial experience in managing CROs and external vendors, including technical oversight, governance, and relationship management. - Proven leadership experience, with the ability to mentor programmers, set strategic direction for a team, and influence cross-functional partners.