Head of Biometrics

Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis’ most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis’ second pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung and other solid tumors. Aktis has a strategic collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of Aktis’ proprietary pipeline.

Aktis Oncology is seeking a Head of Biometrics to build and lead the biometrics function. As the first statistician hire at Aktis, this individual will pair deep, hands-on technical expertise in biostatistics with the leadership skills needed to scale a best-in-class biometrics organization — including statistical programming and data management — in support of Aktis’ growing clinical pipeline of targeted radioconjugates. This is a rare opportunity to shape the strategic and operational foundation of biometrics at a fast-growing, clinical-stage radiopharmaceutical company.

This role will report to the SVP, Head of Global Development Strategy.

RESPONSIBILITIES

This role will drive several areas of strategic importance to Aktis:

• Serve as the senior statistical leader for Aktis, providing strategic and technical direction across all clinical development programs, including AKY-1189, AKY-2519, and future pipeline candidates.
• Design and lead statistical strategy for study protocols and statistical analysis plans, including trial designs appropriate for early- and late-stage oncology and radiopharmaceutical development.
• Build the biometrics function from the ground up as its first hire — recruiting, developing, and managing additional biostatisticians, statistical programmers, and data managers as the pipeline and organization grow.
• Remain hands-on with statistical analysis, programming oversight, and regulatory deliverables while the function scales, balancing individual contribution with team leadership.
• Oversee statistical input into regulatory submissions (e.g., INDs, briefing documents, NDAs/BLAs) and represent biometrics in interactions with FDA and other health authorities.
• Establish biometrics processes, standards, and infrastructure (e.g., CDISC standards, statistical computing environment, data review conventions) appropriate for a scaling clinical-stage company.
• Partner cross-functionally with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Translational Medicine to ensure data integrity and alignment on trial design and analysis.
• Manage relationships with CROs and external statistical and programming vendors, ensuring the quality and timeliness of deliverables.
• Contribute statistical expertise to due diligence, publications, and external presentations as needed.

QUALIFICATIONS

• PhD (preferred) or MS in Biostatistics, Statistics, or a related quantitative field.
• 7-10+ years of biostatistics experience in the pharmaceutical/biotech industry, including oncology drug development; experience with radiopharmaceuticals or targeted therapies is a plus.
• Demonstrated leadership experience helping build and/or lead a biometrics function, including hiring and managing biostatisticians, statistical programmers, and/or data managers.
• Willingness and ability to work hands-on as an individual contributor as the first member of the function, while planning for team growth.
• Deep expertise in clinical trial design, statistical analysis plans, and regulatory statistics, with experience supporting IND/NDA/BLA submissions and health authority interactions.
• Strong knowledge of CDISC standards (SDTM/ADaM) and statistical computing (SAS and/or R).
• Excellent communication skills, with the ability to translate complex statistical concepts for cross-functional and non-technical audiences.
• Experience managing CRO and vendor relationships for statistical programming and biostatistics deliverables.
• Strong desire to be part of a mission‐oriented company leading transformative change for patients.
• Proven demonstration of transparent communication and fostering open and diverse debate.
• Ability to work with agility and manage ambiguity.
• Personifies positive energy and exemplifies respect.

Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation.