VP, Biometrics
Bicycle Therapeutics
June 24, 2026
Remote friendly (Lexington, MA)
United States
$260,000 - $325,000 USD yearly
Clinical Research and Development
Job Title: Vice President, Biometrics
Responsibilities:
- Build, resource, oversee, and take a hands-on role for the Biometrics organization; ensure accountability for clinical study design, statistical methodologies, data analysis, and interpretation.
- Provide strategic statistical input to the drug development portfolio; contribute to oncology and radiopharmaceutical clinical pipelines and support early-stage research/translational sciences as needed.
- Ensure compliant, inspection-ready global operations in biostatistics and clinical/statistical programming; establish and maintain SOPs and ICH GCP-compliant data flow and governance.
- Lead Biometrics participation in CDPs, clinical protocols, investigator brochures, regulatory briefing documents, and scientific publications.
- Develop and execute robust statistical analysis plans (SAPs) supporting clinical protocols with integrity, accuracy, and regulatory compliance.
- Provide specialized statistics for the radioconjugate (BRC) portfolio, including imaging endpoints, dosimetry analysis, and theranostic study designs.
- Manage CRO/vendor selection and ensure quality, consistency, and timeliness of external programming deliverables (e.g., SDTM/ADaM, TFLs).
- Represent Bicycle as lead statistical expert to global regulators (FDA/EMA/MHRA), aligning strategies with current guidelines.
- Recruit, retain, mentor, and develop a biostatistics/programming team; build external collaborations.
Qualifications:
- PhD (or Master’s with equivalent industry experience); proven biometrics leadership; hands-on ability to support day-to-day statistical tasks.
- Oncology drug development experience (Phase I–III); radiopharmaceutical/imaging trial methodology experience highly desirable.
- Knowledge of ICH, FDA, EMA, and global regulatory guidance; experience presenting statistical strategies to regulators; ability to bring assets through development to a successful MMA.
- Expertise in adaptive designs, Bayesian approaches, and master protocols.
- Expert skills in SAS, R, and/or Python; CDISC; experience with open-source validation and modern submission standards.
- Strong communication, negotiation, and cross-functional leadership in a fast-paced matrix environment.
Preferred:
- Bayesian trial design experience; radiopharmacology experience.
Benefits (as listed):
- 28 days annual leave (+ option to buy up to 5)
- Annual bonus; employer pension contribution
- Private Medical Insurance (optical/dental); life assurance (4x basic salary)
- Flexible working; enhanced parental leave; group income protection
- Employee assistance program; Health Cash Plan; subsidized gym membership
- Option grant eligibility to subscribe to Bicycle Therapeutics plc shares
- Cycle to work scheme
Responsibilities:
- Build, resource, oversee, and take a hands-on role for the Biometrics organization; ensure accountability for clinical study design, statistical methodologies, data analysis, and interpretation.
- Provide strategic statistical input to the drug development portfolio; contribute to oncology and radiopharmaceutical clinical pipelines and support early-stage research/translational sciences as needed.
- Ensure compliant, inspection-ready global operations in biostatistics and clinical/statistical programming; establish and maintain SOPs and ICH GCP-compliant data flow and governance.
- Lead Biometrics participation in CDPs, clinical protocols, investigator brochures, regulatory briefing documents, and scientific publications.
- Develop and execute robust statistical analysis plans (SAPs) supporting clinical protocols with integrity, accuracy, and regulatory compliance.
- Provide specialized statistics for the radioconjugate (BRC) portfolio, including imaging endpoints, dosimetry analysis, and theranostic study designs.
- Manage CRO/vendor selection and ensure quality, consistency, and timeliness of external programming deliverables (e.g., SDTM/ADaM, TFLs).
- Represent Bicycle as lead statistical expert to global regulators (FDA/EMA/MHRA), aligning strategies with current guidelines.
- Recruit, retain, mentor, and develop a biostatistics/programming team; build external collaborations.
Qualifications:
- PhD (or Master’s with equivalent industry experience); proven biometrics leadership; hands-on ability to support day-to-day statistical tasks.
- Oncology drug development experience (Phase I–III); radiopharmaceutical/imaging trial methodology experience highly desirable.
- Knowledge of ICH, FDA, EMA, and global regulatory guidance; experience presenting statistical strategies to regulators; ability to bring assets through development to a successful MMA.
- Expertise in adaptive designs, Bayesian approaches, and master protocols.
- Expert skills in SAS, R, and/or Python; CDISC; experience with open-source validation and modern submission standards.
- Strong communication, negotiation, and cross-functional leadership in a fast-paced matrix environment.
Preferred:
- Bayesian trial design experience; radiopharmacology experience.
Benefits (as listed):
- 28 days annual leave (+ option to buy up to 5)
- Annual bonus; employer pension contribution
- Private Medical Insurance (optical/dental); life assurance (4x basic salary)
- Flexible working; enhanced parental leave; group income protection
- Employee assistance program; Health Cash Plan; subsidized gym membership
- Option grant eligibility to subscribe to Bicycle Therapeutics plc shares
- Cycle to work scheme