Senior Director, Statistical Programming

Bicycle Therapeutics • Cambridge, MA

6d • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

Responsibilities

• 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.
• 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.
• Lead, coach, and mentor your team, investing in their professional growth and fostering a culture of high performance and psychological safety.
• Set clear goals and strategic priorities for your team, ensuring their work is directly aligned with departmental and organisational objectives.
• 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.

Benefits

• 401(k) plan with a 4% Company match and immediate vesting
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• Employee assistance program (EAP)
• Time off (eligibility to accrue up to 23 paid time off days per full year worked, the option to buy up to 5 additional days & 10 company nominated holidays)
• 10 Company holidays
• Competitive reward including annual company bonus
• Employee recognition schemes
• Enhanced parental leave policies
• Flexible working environment
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed