Senior Director, Biostatistics at Bicycle Therapeutics

Lexington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Jul, 26

Salary

295000.0

Posted On

29 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Oncology, Clinical trials, People management, Statistical strategy, Regulatory affairs, Clinical development, R, SAS, Simulation, Modeling, Data analysis, Study design, Leadership, Mentorship, GCP

Industry

Biotechnology Research

Description

Company Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating nuzafatide pevedotin (formerly 5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; zelenectide pevedotin (formerly BT8009), a BDC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts, USA. For more information, visit bicycletherapeutics.com Culture is key and all Bicycle employees actively embrace and role model our company values: We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients. We are Dedicated to our Mission. You can’t change the world if you don’t have determination. We are One Team. We only succeed when we work together. Job Description Your mission is to provide expert strategic and statistical leadership for Bicycle's clinical development portfolio. You 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, you will be instrumental in translating complex data into clear, actionable insights that drive our innovative therapies forward for patients. Your Responsibilities Team Leadership & Development You will lead, coach, and mentor your team of biostatisticians, investing in their professional growth and fostering a culture of high performance and psychological safety. You will set clear goals and strategic priorities for the biostatistics function, ensuring its work is directly aligned with departmental and organizational 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. Statistical Strategy & Program Leadership 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. Study Execution & Technical Oversight 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. Qualifications 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. Competencies & Values: 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. Additional Information Flexible working environment 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. Compensation: Salary Range: $235,000 - $295,000 We have shared the expected recruitment base pay range for this full-time position based on the anticipated location. The actual base pay will depend on several factors unique to each candidate, including skills, qualifications, experience, and the actual location of the role. At Bicycle, base pay is just one component of the total reward package. This role is also eligible for Bicycle’s discretionary annual bonus program (or sales incentive program), its comprehensive health and retirement benefit programs, and equity grants. During the hiring process, your Bicycle recruiter can share more about the Company’s total reward package. Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status. Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status. Department: Development Compensation: USD 235000 - USD 295000 - yearly

Responsibilities

You will provide strategic and statistical leadership for the clinical development portfolio while mentoring a team of biostatisticians. You are responsible for shaping study designs, ensuring data integrity, and representing the biostatistics function in regulatory interactions.