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Associate Director, Biostatistics

3 weeks, 6 days ago
United States
Full-time
Lead
Data Scientist
Data Science and Analytics
R
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 22

Description

  • Serve as the statistical lead for one or multiple clinical development projects.
  • Provide technical leadership and biostatistics support for study design, project planning, execution, and scientific publications.
  • Partner with cross-functional teams to provide biostatistics input on development plans, regulatory interactions, and study design.
  • Author or review protocol statistics sections, statistical analysis plans, mock TFLs, and related statistical documentation.
  • Determine sample size and support study randomization, ADaM specifications, CRF design, and DMC charter development.
  • Analyze and interpret clinical study results while ensuring statistical integrity.
  • Contribute to regulatory submissions and support regulatory documents and scientific publications.
  • Oversee vendor and CRO biostatistics teams through TFL development, interim analyses, database locks, and related activities.
  • Conduct exploratory analyses, provide graphic support, and prepare analyses for publications.
  • Evaluate alternative or innovative statistical methods and study design approaches and build relationships with external partners.

Requirements

  • PhD in statistics strongly preferred; an MS in statistics, biostatistics, or mathematics with substantial relevant drug development research experience will be considered.
  • At least 8 years of progressive, relevant clinical trial experience.
  • Experience with phase 3 studies and regulatory submissions preferred.
  • Experience leading teams and working in a matrix organization.
  • Ability to communicate complex statistical information directly to non-statisticians and scientific partners.
  • Excellent presentation and stakeholder communication skills.
  • Experience managing CROs and other data vendors.
  • Advanced knowledge of statistical methods for clinical study design, including adaptive and Bayesian approaches, missing data imputation, multiplicity adjustment, and estimands.
  • Knowledge and proficiency in SAS or R and other industry computational tools.
  • Knowledge of CDISC standards, including SDTM and ADaM, and familiarity with ICH guidelines and FDA/EMA regulatory guidance.
  • Experience planning, running, and documenting simulations, including clinical trial simulations.
  • Experience working in a remote virtual environment.
  • Ability to work in a fast-moving organization, navigate ambiguity, and embody Apogee’s C.O.R.E. values.
  • Up to 15% travel required, including mandatory in-person attendance at All Hands meetings twice per year and possible additional travel for key Phase 3 meetings.

Benefits

  • Anticipated salary range of $195,000 to $225,000 per year.
  • Market-competitive compensation package with performance bonus opportunities.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO plus two one-week company-wide shutdowns each year and dedicated paid sick leave.
  • Access to resources and support for professional development.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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