Original listing text, shown exactly as published by the company.
Key Responsibilities
- Contributor on regulatory submissions
- 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
Ideal Candidate
- 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
- Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
- 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
- Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office
The anticipated salary range for candidates for this role will be $195,000 - $225,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
