Job Description
Provide strategic and technical leadership for the statistical programming function, driving delivery of high-quality data and analysis for the clinical portfolio. Ensure operational excellence across programming activities; partner with Biostatistics and Clinical Development; lead and mentor a team of programmers to support clinical trials and regulatory submissions.
YOUR RESPONSIBILITIES
Strategic & Technical Leadership
- Accountable for statistical programming deliverables for assigned clinical development programs (timelines, quality, compliance).
- Senior technical expert on CDISC standards (SDTM, ADaM), programming methodologies, and data submission strategies; guide team/vendors on complex implementations.
- Partner with the Biometrics Lead on long-term vision/strategy, including resource planning, technology adoption, and talent development.
Operational Excellence & Process Innovation
- Develop, implement, and optimize global SOPs, tools, and innovative workflows to improve efficiency and quality.
- Select and govern CROs/external vendors; ensure harmonized programming approach and partner accountability.
- Ensure programming activities/documentation are inspection-ready; oversee data integrity and compliance with ICH/GCP.
Team Leadership & Development
- Lead, coach, mentor; foster high performance and psychological safety.
- Set goals/priorities aligned with departmental/organizational objectives.
- Role model Bicycle Values; embed collaboration, accountability, innovation.
Qualifications / Skills & Competencies
- Deep expertise in statistical programming in biotech/pharma.
- Track record leading programming strategy for clinical development (preferably oncology).
- Expert SAS programming; CDISC (SDTM/ADaM); experience preparing data for regulatory submissions (e.g., NDA/BLA).
- Experience managing CROs/vendors (technical oversight, governance, relationships).
- Leadership experience mentoring programmers and influencing cross-functional partners.
Benefits
- 401(k) plan with 4% company match.
- Medical/dental/vision insurance (premiums covered by Company) for eligible employees and families.
- Health and Dependent Care Flexible Spending Accounts.
- Employee assistance program (EAP).
- Time off: up to 23 paid time off days per year; option to buy up to 5 additional days; 10 company holidays.
- Competitive reward including annual company bonus.
- Enhanced parental leave policies.
- Eligibility for option grant to subscribe to shares in Bicycle Therapeutics plc.