Associate Director, Biostatistics

Apogeetherapeutics

Remote
$195,000 - $225,000/ year py
Remote
Statistical lead for clinical studies
Expert biostatistics input on development plans
Author/review statistical analysis plans
Apogee Therapeutics is seeking an Associate Director of Biostatistics to lead statistical efforts in clinical studies and regulatory submissions. The ideal candidate will have extensive experience in clinical trial design and statistical analysis, as well as a strong background in managing CRO teams and communicating complex statistical concepts to diverse stakeholders

Job Summary

  • Act as the statistical lead for one or multiple projects, providing technical leadership and statistical support on study design, project planning, conduct and execution of clinical studies, and scientific publications.
  • Partner closely with cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design.
  • Contribute to regulatory submissions and oversee vendor/CRO biostatistics teams, ensuring the delivery of high-quality and timely reports.

Matching Summary

Match Score: 85

Apogee Therapeutics is seeking an Associate Director of Biostatistics to lead statistical efforts in clinical studies and regulatory submissions. The ideal candidate will have extensive experience in clinical trial design and statistical analysis, as well as a strong background in managing CRO teams and communicating complex statistical concepts to diverse stakeholders.

Salary

$195,000 - $225,000/ year

Skills & Requirements

Must-have

  • Statistical lead for clinical studies
  • Expert biostatistics input on development plans
  • Author/review statistical analysis plans
  • Oversee vendor/CRO biostatistics teams
  • Experience managing CROs and other data vendors
  • Knowledge of CDISC standards (SDTM, ADaM)
  • Knowledge of ICH guidelines and regulatory guidance

Nice-to-have

  • Growth mindset and psychological safety
  • Ability to navigate ambiguity
  • Experience in remote virtual environments

Key Requirements

  • PhD in statistics strongly preferred; MS with depth of experience considered
  • Minimum of 8 years' progressive clinical trial experience
  • Experience with phase 3 study and regulatory submission preferred
  • Experience leading teams and working in a matrix organization
  • Advanced knowledge of statistical methods in clinical study designs
  • Proficiency in SAS or R and other industry computational tools
  • Experience planning, running and documenting simulations

Work Rights

Not specified

Tailored Resume

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