Apogee Therapeutics is hiring a
Director Biostatistics

Summary

Join Apogee Therapeutics as a Director of Biostatistics and contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. In this position, you will function as the statistical lead for one or more 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 or biostatistics and a depth of relevant experience in drug development statistical research will be considered
• A minimum of 10 years’ experience in progressive and relevant clinical trial experience
• Advanced knowledge of statistical methods in clinical study designs (including adaptive designs, Bayesian methods, and platform trials)
• Statistical analysis methods (such as Bayesian analysis, missing data imputation, and multiplicity adjustment with graphical approaches)
• Expertise in analyzing continuous, binary, count, and time-to-event data
• Strong experience in designing, executing, analyzing, and interpreting simulations (including clinical trial simulations)
• 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 leading teams and working in a matrix organization
• Ability to communicate and collaborate 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
• Experience working with in a remote virtual environment

Responsibilities

• Function as the statistical lead for one or more studies
• Provide technical leadership and statistical support on the design, conduct, and execution of clinical studies
• Partner closely with cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design
• Author/review statistics section in the protocol
• Determine sample size
• Author/review statistical analysis plan and mock TFL
• Review study randomization files, ADaM specs, CRF design, DMC charter
• Analyze and interpret clinical study results
• Ensure 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