Associate Director, Biostatistics

• Acting 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
• Partnering closely with cross-functional teams
• 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
• Contributor on regulatory submissions
• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications
• Oversee the vendor/CRO biostatistics teams
• Execute or oversee individual projects
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners
• Ensure the delivery of high quality and timely reports

• PhD in statistics strongly preferred
• MS in statistics, biostatistics or mathematics with 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
• Excellent communication with an ability to present to a variety of stakeholders
• Experience managing CROs and other data vendors
• Strong leader with a growth mindset
• Ability to keep pace in a fast-moving organization and navigate ambiguity
• Advanced knowledge of statistical methods in clinical study designs
• 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
• Experience working in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings held twice per year

Experience with phase 3 study and regulatory submission is preferred

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• 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