Senior Director, Biostatistics

Bicycle Therapeutics•Lexington, MA

1d•Hybrid

About The Position

The Senior Director, Biostatistics will provide expert strategic and statistical leadership for Bicycle's clinical development portfolio. This role involves leading a team of biostatisticians, offering quantitative insights to shape study designs, guide program strategy, and ensure the integrity of clinical data. As a key leader in the Biometrics function, this individual will be instrumental in translating complex data into clear, actionable insights to advance innovative therapies 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).
Deep understanding of simulation and modeling techniques.

Nice To Haves

Knowledge & Expertise: Core Expertise: Guiding statistical and quantitative strategy across multiple functions, shaping the company's approach to clinical study design and data analysis.
Data / Insight: Providing foresight and strategic interpretation of complex clinical trial data, simulations, and statistical models to guide long-term development strategy.
Knowledge Sharing: Representing the Biostatistics function externally and internally as a thought leader, promoting best practices and enhancing Bicycle's scientific reputation.
Task / Project Delivery: Overseeing a portfolio of clinical programs, ensuring all biostatistical strategies are aligned, resourced, and executed to meet organizational goals.
Problem-Solving: Solving systemic, organization-wide challenges, such as defining the statistical strategy for a pivotal trial or addressing complex regulatory questions.
Strategic Impact: Contributing directly to organizational strategy and direction by ensuring a cutting-edge, statistically robust approach is embedded across our clinical pipeline.
Independence Autonomy: Shaping the cross-functional direction of clinical programs, participating in key strategic decisions on study design and data interpretation.
Decision-Making: Making enterprise-level decisions on statistical strategy and methodology that have organization-wide implications for our clinical programs.
Leadership / Mentorship: Developing future organizational leaders, providing coaching to senior statistical professionals and ensuring robust succession planning for your function.
One Team Collaboration: Creating alignment across multiple senior teams (Biometrics, Clinical, Medical, Regulatory), ensuring biostatistics is a seamless and strategic partner in our development engine.
Inclusive Leadership: Embedding inclusivity and collaboration into the culture, acting as a role model for how to integrate diverse scientific and quantitative perspectives.
Mentorship / Support: Coaching senior leaders and statistical experts, actively engaging in succession planning to build our future leadership pipeline.
Adventurous Innovation: Championing the adoption of innovative statistical methodologies and practices that have the potential to transform our approach to clinical development.
Risk-Taking: Taking calculated, high-level risks, such as using novel study designs or advanced simulation techniques, to position our programs for success.
Change Leadership: Leading the organization confidently through major data readouts and regulatory submissions, providing clear direction and fostering enterprise-wide alignment.
Dedicated to our Mission Accountability: Ensuring organizational priorities for your programs remain directly aligned with our core mission, holding the wider team accountable for data integrity and quality.
Resilience: Sustaining focus and determination during high-stakes challenges, providing a steadying influence through key clinical milestones and regulatory reviews.
Inspiration: Inspiring organization-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, focusing on professional growth and fostering a culture of high performance and psychological safety.
Set clear goals and strategic priorities for the biostatistics function, ensuring alignment with departmental and organizational objectives.
Champion Bicycle Values, acting as a role model and embedding a culture of collaboration, accountability, and innovation.
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 regulatory interactions, providing statistical expertise for meetings and authoring key sections of regulatory documents.
Provide senior oversight for all study-level biostatistical activities, including vendor work, ensuring high 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).

Benefits

Hybrid style working arrangement (3 days onsite per week in Lexington, MA office, remainder remote)
Competitive reward including annual company bonus
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.