Senior Director, Statistical Programming

Bicycle Therapeutics•Cambridge, MA

6d•Hybrid

About The Position

The Senior Director, Statistical Programming will provide strategic and technical leadership for the statistical programming function. This role drives the delivery of high-quality data and analysis for Bicycle's clinical portfolio, ensuring operational excellence across all programming activities. The position serves as a key strategic partner to Biostatistics and Clinical Development, and leads and mentors a team of programmers to support the successful execution of 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

Pension 12% employer contribution
Private Medical Insurance (PMI) (including optical and dental cover)
Health Cash Plan
Group Life Assurance (4x basic salary)
Group Income Protection
Employee Assistance Program (EAP)
Cycle to Work scheme
Gym membership (subsidized by Company if on campus, subsidized by PMI if joined elsewhere)
28 days annual leave in addition to bank holidays & the option to buy up to 5 additional days annually
Competitive reward including annual company bonus
Employee recognition schemes
Enhanced parental leave policies
Flexible working environment
State-of-the-art campus environment with on campus restaurant and Montessori nursery
Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.