Senior Director, Statistical Programming

Apogee Therapeutics IncA

Remote, US
Base: $270,000 - $295,000; bonus/equity: performan...
Remote
12-15 years clinical trial programming experience
Advanced sas programming skills with cdisc standards
Experience managing cros and external vendors
Apogee Therapeutics Inc. is seeking a Senior Director of Statistical Programming to lead their programming efforts for clinical trials in a remote capacity. The role requires extensive experience in clinical trial programming, SAS proficiency, and a strong understanding of regulatory submissions, all within a fast-paced biotech environment

Job Summary

  • The role involves leading programming activities for clinical trials while ensuring timely and high-quality deliverables for regulatory submissions.
  • Apogee Therapeutics offers a fast-paced environment where employees can actively shape company culture based on C.O.R.E. values.
  • The position includes managing external vendors, mentoring team members, and driving process improvements through automation and AI solutions.

Matching Summary

Match Score: 85

Apogee Therapeutics Inc. is seeking a Senior Director of Statistical Programming to lead their programming efforts for clinical trials in a remote capacity. The role requires extensive experience in clinical trial programming, SAS proficiency, and a strong understanding of regulatory submissions, all within a fast-paced biotech environment.

Salary

Base: $270,000 - $295,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, three weeks PTO, two one-week shutdowns

Skills & Requirements

Must-have

  • 12-15 years clinical trial programming experience
  • Advanced SAS programming skills with CDISC standards
  • Experience managing CROs and external vendors
  • Knowledge of regulatory submission processes (NDA/BLA)
  • Leadership experience in biotech/pharma industry

Nice-to-have

  • Experience with R or other statistical languages
  • Ambition to leverage AI in drug development workflows
  • Familiarity with cloud environments and scalable analytics
  • Commitment to fostering inclusive team culture
  • Adaptability in fast-paced growth environment

Key Requirements

  • Master's Degree in Statistics, Biostatistics, Mathematics, or Computer Science
  • Minimum 12-15 years progressive clinical trial programming experience
  • In-depth knowledge of SDTM, ADaM, and controlled terminology
  • Experience supporting NDA/BLA/MAA regulatory submissions
  • Ability to travel up to 15% including mandatory in-person meetings

Work Rights

Not specified

Tailored Resume

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