Director - Senior Director, Statistical Programming

SmartRecruiters, Inc.; Cambridge; Hybrid; GBP 140,000 - 200,000; Full time

Benefits offered by this job

Pension 12%

Private Medical Insurance

Health Cash Plan

Group Life Assurance

Group Income Protection

Employee Assistance Program

Cycle to Work

Gym membership

28 days annual leave + bank holidays

Job summary

Bicycle Therapeutics in Cambridge, UK, seeks a Director/Senior Director of Statistical Programming to lead the programming function across the clinical portfolio. You will deliver strategic direction, ensure regulatory-ready data, and mentor a high-performance team in CDISC standards and SDTM/ADaM.

The role demands collaboration with Biostatistics and Clinical Development, oversight of CROs, and a track record of driving quality, timelines, and data integrity in oncology or biopharma.

Qualifications

• Expert knowledge of statistical programming and clinical development.
• Deep understanding of regulatory impact on programming deliverables.
• Proven ability to lead a programming function across development programs.

Responsibilities

• Provide strategic leadership for all programming deliverables and ensure timelines and quality.
• Serve as senior expert on CDISC standards and data submission strategies; guide team and vendors.
• Partner with Biometrics Lead to define long-term strategy, resource planning, and talent development.
• Oversee SOPs, tools, and workflows to improve efficiency and quality.
• Oversee CRO/vendor governance to ensure high-quality, timely deliverables.
• Ensure inspection-ready documentation and data integrity in line with ICH/GCP.

Skills

SAS programming

CDISC SDTM/ADaM

Leadership & strategy

Vendor management

Regulatory submissions

Tools

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Job description

Director - Senior Director, Statistical Programming

• Full-time
• Department: Development

About Bicycle Therapeutics

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 BT5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of Bicycle® Radioconjugates (BRCs) and imaging agents; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle®technology to develop therapies to treat diseases in a range of therapeutic areas.

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

Cultureis key and all Bicycle employees actively embrace and role model our company values:

• We areAdventurous. We believe it’s the way to deliver extraordinary results for our patients.
• We areDedicated to our Mission. You can’t change the world if you do not have determination.
• We areOne Team. We only succeed when we work together.

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 is2-3 days onsite per weekat our Cambridge, UK office, with the remainder of your working week remote.

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.
• 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.
• 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.
  • 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.
    • 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)
    • Time off (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
    • 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.

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.