RemoteLeaf Logo
Log in Sign up

Associate Director, Biostatistics

3 hours, 17 minutes 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 17

Description

  • Act as the statistical lead for one or more clinical development projects.
  • Provide technical leadership and statistical support for study design, planning, conduct, and execution.
  • Author or review protocol statistics sections, statistical analysis plans, and mock TFLs.
  • Determine sample sizes and review study randomization files, ADaM specifications, CRF designs, and DMC charters.
  • Analyze and interpret clinical study results while ensuring statistical integrity.
  • Support regulatory submissions and provide statistical input for development plans and regulatory interactions.
  • Oversee vendor and CRO biostatistics teams through TFL development, interim analyses, safety board meetings, and database locks.
  • Conduct exploratory analyses and provide graphical and publication support for studies.
  • Evaluate innovative statistical methods and study design approaches.
  • Build relationships with CROs and external partners to meet project needs and deliver timely, high-quality reports.

Requirements

  • PhD in statistics strongly preferred; MS in statistics, biostatistics, or mathematics with substantial relevant drug development research experience will be considered.
  • Minimum of 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 to non-statisticians and scientific partners.
  • Excellent presentation and stakeholder communication skills.
  • Experience managing CROs and other data vendors.
  • Advanced knowledge of clinical study design methods, including adaptive and Bayesian approaches, missing data imputation, multiplicity adjustment, and estimands.
  • 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, ambiguous environment and align with Apogee’s C.O.R.E. values.
  • Ability to travel up to 15%, including mandatory in-person attendance at All Hands meetings twice per year and additional travel for key Phase 3 meetings.

Benefits

  • Anticipated salary range of $195,000 to $225,000 per year.
  • Market-competitive compensation package with base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support with access to resources to grow your career.
  • Regular in-person all-team meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Puck

Lead Data Scientist

Puck 1-10 Internet Software & Services

Earnest is hiring a Lead Data Scientist to own pricing systems and experimentation that improve conversion, retention, profitability, and revenue in a cross-functional fintech environment.

Anywhere Full-time Lead Data Scientist
$180k-$225k
Apache Airflow AWS dbt LLM Looker NLP Python R SQL
2 minutes ago
instacart.careers

Data Science Manager, Shopping Experience

instacart.careers 1K-5K Internet Software & Services

Instacart is seeking a Data Science Manager to lead analytics and experimentation for the shopping experience across the consumer journey, helping improve conversion, retention, and shopper satisfaction at scale.

United States Full-time Senior Data Scientist
$182k-$230k
Generative AI LLM Machine Learning Python R SQL
17 minutes ago
Power Digital Marketing

Marketing Science Product Engineer

Power Digital Marketing 251-1K Media

Power Digital is hiring a Marketing Science Product Engineer to turn MMM and causal measurement methodology into production-ready Python utilities that support product-approved workflows across teams and UI environments.

Argentina Full-time Senior Data Scientist Full-stack Engineer
GCP Machine Learning Matplotlib NumPy Pandas Plotly Python SciPy Seaborn Snowflake SQL
32 minutes ago
Mozilla

Sr Staff Quantitative User Researcher

Mozilla 251-1K Internet Software & Services

Mozilla is hiring a Senior Staff Quantitative User Researcher to lead quantitative research for Firefox, turning user and behavioral data into insights that shape product strategy and decisions.

Canada Full-time Lead Data Scientist UX Researcher
$95k-$140k
Agile R SQL
32 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers