Apogee Therapeutics

Associate Director, Biostatistics

Apogee Therapeutics

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $195,000 - $215,000 per year

Job Level

Senior

About the role

  • 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

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
  • 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
Benefits
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • 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
  • We provide 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical analysisstatistical methodsclinical study designBayesian methodsmissing data imputationmultiplicity adjustmentestimandSASRclinical trial simulations
Soft Skills
communicationleadershiprelationship buildingteamworkadaptabilitypresentation skillsgrowth mindsetpsychological safetyproblem-solvingstakeholder engagement
Certifications
PhD in statisticsMS in statisticsbiostatisticsmathematics