Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.
Calico is seeking a clinical biostatistician with experience in all phases of clinical development, including extensive experience in First-in-Human (FIH) through Proof-of-Concept studies, and in non-traditional (translation or experimental studies) early phase studies in bringing novel therapeutics to the clinic. The candidate will also have experience in design and analysis of preclinical studies and analysis of large data sets. The Senior Director of Biostatistics will join a small and growing drug development organization responsible for advancing exciting drug candidates into clinical trials to treat diseases with high unmet medical need and for advancing the understanding of human aging The objective is to create an agile team to navigate new terrain in the approach to the early stages of drug development and would involve participation in cross-functional team meetings providing statistical support to early stage development programs. The successful candidate is also expected to consult to teams in preclinical stages of development on study design and analytic methods, as well as collaborate with data scientists analyzing large nonclinical and clinical data sets.
Calico’s approach to drug development is supported by some of the world’s most talented life scientists. This position offers a unique opportunity to build a creative, effective and efficient approach to drug development at the leading edge of evolution in scientific knowledge, and the opportunity to collaborate with our innovative Computational group, including computational biologists, data scientists, machine learning and data platform engineers.
Design and authorship of statistical analysis plans for clinical protocols and final functional review
Analysis of nonclinical and clinical datasets and final functional review
Written and oral communication of statistical plans and results to senior leadership
Authorship of Clinical Study Reports and final functional review
Work collaboratively with cross-functional teams to develop nonclinical and clinical study designs and endpoints, including Phase 0-Phase 2 studies across multiple therapeutic areas
Represent Calico statistics function with vendors, industry collaborators, and academic collaborators
Assist the Quality Assurance function to generate and review SOPs involving the Biostatistics function at Calico
Manage and be accountable for a group of statisticians, with expertise in clinical and/or nonclinical statistics
Ph.D. in statistics or biostatistics
A minimum of 10 years of drug development industry experience (Biotechnology or Pharmaceutical), or equivalent, in clinical biostatistics with a significant amount of this experience supporting early drug development (FIH through to proof-of-concept)
Expertise in statistical aspects of clinical trial design
Familiarity in statistical methods of nonclinical trial design and analysis
Ability to lead analysis, data visualization and reporting of clinical and nonclinical trial results
Ability to review experimental data or large observational data sets to assist in biomarker development and nonclinical/clinical trial design
Software capability in trial design and data analysis such as R Studio and SAS
Detail-oriented mindset including experience in teamwork and productive collaboration on cross-functional complex projects
Self-motivated with strong track record of driving results
Excellent verbal and written communication skills
Management experience is preferred, but not required
Must be willing to work onsite at least three days per week
Calico requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Calico will consider requests for Reasonable Accommodations.