Senior Director, Biostatistics

Bicycle Therapeutics • Lexington, MA

1d • Hybrid

About The Position

This role provides expert strategic and statistical leadership for Bicycle's clinical development portfolio. The Senior Director will lead a team of biostatisticians, providing quantitative deep thinking to shape study designs, guide program strategy, and ensure the integrity of our clinical data. As a key leader in the Biometrics function, this individual will be instrumental in translating complex data into clear, actionable insights that drive innovative therapies forward for patients.

Requirements

• Extensive experience and a record of senior leadership in biostatistics within the biopharmaceutical industry, with a deep focus on oncology clinical trials.
• Proven experience in people management and leading high-performing technical teams.
• Demonstrated ability to develop and execute the statistical strategy for clinical development programs and translate complex data into clear, impactful insights.
• Authoritative knowledge of advanced statistical methods, regulatory guidelines (GCP), and their application to all phases of clinical development.
• Proficiency with statistical programming languages (e.g., R, SAS) and a deep understanding of simulation and modeling techniques.

Nice To Haves

• Knowledge & Expertise: Core Expertise: You guide the statistical and quantitative strategy across multiple functions, shaping the company's approach to clinical study design and data analysis.
• Data / Insight: You provide foresight and strategic interpretation of complex clinical trial data, simulations, and statistical models to guide long-term development strategy.
• Knowledge Sharing: You represent the Biostatistics function externally and internally as a thought leader, promoting best practices and enhancing Bicycle's scientific reputation.
• Job Complexity: Task / Project Delivery: You oversee a portfolio of clinical programs, ensuring that all biostatistical strategies are aligned, resourced, and executed to meet organisational goals.
• Problem-Solving: You solve systemic, organisation-wide challenges, such as defining the statistical strategy for a pivotal trial or addressing complex regulatory questions.
• Strategic Impact: You contribute directly to organisational strategy and direction by ensuring a cutting-edge, statistically robust approach is embedded across our clinical pipeline.
• Independence: Autonomy: You shape the cross-functional direction of clinical programs, participating in key strategic decisions on study design and data interpretation.
• Decision-Making: You make enterprise-level decisions on statistical strategy and methodology that have organisation-wide implications for our clinical programs.
• Leadership / Mentorship: You develop future organisational leaders, providing coaching to senior statistical professionals and ensuring robust succession planning for your function.
• Values & Behaviours: One Team Collaboration: You create alignment across multiple senior teams (Biometrics, Clinical, Medical, Regulatory), ensuring biostatistics is a seamless and strategic partner in our development engine.
• Inclusive Leadership: You embed inclusivity and collaboration into the culture, acting as a role model for how to integrate diverse scientific and quantitative perspectives.
• Mentorship / Support: You coach senior leaders and statistical experts, actively engaging in succession planning to build our future leadership pipeline.
• Adventurous Innovation: You champion the adoption of innovative statistical methodologies and practices that have the potential to transform our approach to clinical development.
• Risk-Taking: You take calculated, high-level risks, such as using novel study designs or advanced simulation techniques, to position our programs for success.
• Change Leadership: You lead the organisation confidently through major data readouts and regulatory submissions, providing clear direction and fostering enterprise-wide alignment.
• Dedicated to our Mission: Accountability: You ensure organisational priorities for your programs remain directly aligned with our core mission, holding the wider team accountable for data integrity and quality.
• Resilience: You sustain focus and determination during high-stakes challenges, providing a steadying influence through key clinical milestones and regulatory reviews.
• Inspiration: You inspire organisation-wide commitment to our purpose, articulating a compelling quantitative vision that connects robust data directly to patient outcomes.

Responsibilities

• Lead, coach, and mentor a team of biostatisticians, investing in their professional growth and fostering a culture of high performance and psychological safety.
• Set clear goals and strategic priorities for the biostatistics function, ensuring its work is directly aligned with departmental and organizational 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.
• Serve as the program-level biostatistical lead for key development assets, providing strategic input and quantitative expertise to shape the clinical development plan.
• Collaborate with senior leaders in Medical, Clinical Research, and Regulatory Affairs to address critical questions and support data-driven clinical decision-making.
• Represent the biostatistics function in all regulatory interactions, including providing statistical expertise for meetings and authoring key sections of regulatory documents.
• Provide senior oversight for all study-level biostatistical activities, including work conducted by vendors, to ensure the highest standards of quality and timeliness.
• Apply advanced statistical methods, including modeling and simulation, to solve challenging issues in study design, analysis, and interpretation.
• Provide expert review and approval for key statistical documents, including protocols and Statistical Analysis Plans (SAPs), ensuring they are fit for purpose.

Benefits

• 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
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

What This Job Offers

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