Associate Director, Biostatistics

 

About Apogee Therapeutics 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, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking an Associate Director of Biostatistics. In this position you will be acting as the statistical lead for one or multiple projects, providing technical leadership and statistical support on the study design, project planning, conduct and execution of clinical studies, and scientific publications. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity.

Key Responsibilities

• 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 Apogee’s clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
• Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies
• 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

Ideal Candidate

• 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’ 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 and delivering 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 standard including SDTM, ADaM
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience in planning, running and documenting simulations,