We are seeking an Associate Director of Biostatistics to provide technical leadership and statistical support on the study design, project planning, conduct and execution of clinical studies, and scientific publications.
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 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
- 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, including clinical trial simulations
- Experience working in a remote virtual environment
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Benefits
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- Competitive time off, including 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
