5-7 years of statistical programming experience in biotech or pharmaceuticals
Proven leadership in programming strategy for clinical development, ideally in oncology
Expert-level SAS programming skills and CDISC standards (SDTM/ADaM)
Experience with regulatory submissions (e.g., NDA/BLA) preparation
Strong track record in managing CROs and vendor relations
Responsibilities
Lead strategic direction and deliverables for statistical programming in clinical trials
Act as the senior technical expert on CDISC standards and programming methodologies
Collaborate with Biometrics Lead on long-term strategy for the programming function
Develop and optimize Standard Operating Procedures (SOPs) for functional excellence
Oversee vendor governance and ensure high-quality programming deliverables
Mentor and coach programming team to align with organizational goals
Foster a culture of collaboration, accountability, and innovation
Benefits
401(k) plan with 4% matching and immediate vesting
Full medical, dental, and vision insurance coverage
Health and Dependent Care Flexible Spending Accounts
Employee assistance program (EAP)
Up to 23 paid time off days per year, plus options to buy additional days
10 company-nominated holidays
Annual company bonus and recognition schemes
Enhanced parental leave policies
Flexible working environment
Eligibility for share options in Bicycle Therapeutics plc
Full Job Description
Working Classification:
At Bicycle, we benefit from a hybrid style working arrangement, allowing employees where possible the opportunity to collaborate and engage with their coworkers in person while also benefiting from the flexibility of remote working. A typical hybrid arrangement for this role is 2-3 days onsite per week at our Lexington, MA office, with the remainder of your working week remote.
Job Description
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.
YOUR RESPONSIBILITIES
Strategic & Technical Leadership
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.
Operational Excellence & Process Innovation
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.
Team Leadership & Development
You will lead, coach, and mentor your team, investing in their professional growth and fostering a culture of high performance and psychological safety.
You will set clear goals and strategic priorities for your team, ensuring their work is directly aligned with departmental and organisational 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.
WHO ARE YOU: SKILLS & COMPETENCIES
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.
Qualifications
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.
Additional Information
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.
Compensation
Salary Range: $215,000 - $270,000
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About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle Therapeutics is developing a pipeline of Bicycles for oncology, immuno-oncology, and other therapeutic areas.
