Apogee Therapeutics is hiring a
Associate Director

Summary

Join Apogee Therapeutics as an Associate Director of Biostatistics and contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. In this position, you will act as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct, and execution of clinical studies.

Requirements

• 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 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
• Ability to keep pace in a fast-moving organization and navigate ambiguity, and work in a fully remote environment
• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment
• Knowledge and proficiency in the following: SAS or R and other industry computational tools, CDISC standard including SDTM, ADaM, ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience in planning, running and documenting simulations, including clinical trial simulations

Responsibilities

• Acting as the statistical lead for one or multiple studies
• Providing technical leadership and statistical support on the design, conduct, and execution of clinical studies
• Partnering closely with cross-functional teams and providing expert biostatistics input on development plans, regulatory interactions, and study design
• 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
• Ensuring statistical integrity

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year