Head of Biometrics

Aktis Oncology

• $160K — $200K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • PhD (preferred) or MS in Biostatistics, Statistics, or related field.
  • 7-10+ years of biostatistics experience in pharma/biotech, especially in oncology; radiopharmaceuticals experience beneficial.
  • Leadership in building and managing biostatistics teams, including recruiting talent.
  • Hands-on individual contributor skills with an eye towards team development as company grows.
  • Expertise in clinical trial design, statistical analysis plans, and regulatory statistics, including IND/NDA/BLA submissions.
  • Knowledge of CDISC standards (SDTM/ADaM) and statistical software (SAS/R).
  • Strong communication skills to convey complex statistics to diverse audiences.

Responsibilities

  • Serve as the senior statistical leader, guiding strategy across all clinical programs.
  • Design and oversee statistical strategies for study protocols and analysis plans.
  • Build the biometrics function from scratch, including team recruitment and development.
  • Engage in hands-on statistical analysis while leading team initiatives during growth.
  • Manage statistical content for regulatory submissions and represent biometrics in FDA interactions.
  • Establish biometrics processes and infrastructure suitable for a scaling company.
  • Collaborate with various departments to ensure data integrity and alignment on trial designs.
  • Oversee relationships with CROs and external vendors to ensure deliverable quality and timeliness.

Benefits

  • Opportunity to shape the strategic direction of biostatistics in a growing company.
  • Be part of a mission-driven organization focused on transformative patient care.
  • Engagement with innovative early- and late-stage oncology research.
  • Chance to work cross-functionally with multiple departments.
Full Job Description
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.

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