Associate Director, Biostatistics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well‑funded, Nasdaq‑listed company that offers the opportunity to work in a fast‑paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a clinical‑stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well‑established mechanisms of action and incorporating advanced antibody engineering to optimize half‑life and other properties. Zumilokibart (APG
777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD) and asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best‑in‑class efficacy and dosing through monotherapies and combinations of its novel antibodies.

• Caring
• Original
• Resilient
• Egoless

We are seeking an Associate Director of Biostatistics to 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. The role includes partnering closely with cross‑functional teams and providing expert biostatistics input on development plans, regulatory interactions, and study design, including authoring or reviewing statistical sections in protocols, protocols, statistical analysis plans, mock TFLs, ADaM specifications, CRF design, DMC charters, and interpreting clinical study results.

• Contributor on regulatory submissions
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generate or review study randomization, and sample size/power estimations
• Oversee vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, including meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and clinical trial team

• PhD in statistics strongly preferred; candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered
• A minimum of 8 years of experience in progressive and relevant clinical trial experience
• Experience with phase 3 study and regulatory submission is preferred
• Experience leading teams and working in a matrix organization
• Ability to communicate and work directly with non‑statisticians, imparting complex statistical information to scientific development partners and researchers
• Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
• Experience managing CROs and other data vendors
• Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Ability to keep pace in a fast‑moving organization and navigate ambiguity
• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including missing data imputation, multiplicity adjustment, estimand, Bayesian method, etc.
• Knowledge and proficiency in SAS or R and other industry computational tools
• Knowledge of CDISC standards including SDTM, ADaM
• Knowledge of ICH guidelines, FDA / EMA / other…