Head of Biometrics

Aktis Oncology Inc • Boston, MA

9d • $261,000 - $319,000

About The Position

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.

Requirements

• 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.

Nice To Haves

• experience with radiopharmaceuticals or targeted therapies is a plus.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior