Director, Biostatistics

Summary

Join Apogee Therapeutics as their Director of Biostatistics and act as the statistical lead for clinical studies. You will provide technical leadership and statistical support for study design, conduct, and execution. Collaborate closely with cross-functional teams, offering expert biostatistical input on development plans and regulatory interactions. Responsibilities include authoring/reviewing statistical sections in protocols, determining sample sizes, analyzing clinical study results, and ensuring statistical integrity. You will also oversee vendor/CRO biostatistics teams and build relationships with external partners. This role requires a PhD in statistics (or MS with extensive experience), 10+ years of relevant experience, advanced knowledge of statistical methods, proficiency in SAS or R, and excellent communication skills.

Requirements

• Possess a 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
• Have a minimum of 10 years’ experience in progressive and relevant clinical trial experience
• Have 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), and expertise in analyzing continuous, binary, count, and time-to-event data
• Have strong experience in designing, executing, analyzing, and interpreting simulations, including clinical trial simulations
• Possess knowledge and proficiency in SAS or R and other industry computational tools
• Have knowledge of CDISC standard including SDTM, ADaM
• Have knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Have experience leading teams and working in a matrix organization
• Have the ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
• Possess excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
• Have experience managing CROs and other data vendors
• Be a strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Have the ability to keep pace in a fast-moving organization and navigate ambiguity
• Have experience working with in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Have the ability and willingness to travel up to 25% or as needed by the business

Responsibilities

• Be a key contributor on regulatory submissions and communication with global regulatory authorities
• 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

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• 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
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve