Strategic Leader, Statistical Programming

SmartRecruiters, Inc.

Cambridge

Hybrid

GBP 120,000 - 180,000

Full time

12 days ago
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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

Job description

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.

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