layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Associate Director/Director, Biostatistics at calicolabs

Independently lead biostatistical support for assigned therapeutic programs and clinical studies across development phases
Develop statistical strategies aligned with clinical development objectives and regulatory requirements
Collaborate with clinical and scientific teams to evaluate study design alternatives, assess risks and uncertainties, and support data-driven development decisions
Provide statistical input into clinical development plans, study protocols, endpoint selection, sample size considerations, and overall evidence-generation strategies
Develop and evaluate innovative trial designs, including adaptive designs, Bayesian approaches, and simulation-based methods, as appropriate
Provide statistical expertise for studies involving small sample sizes, heterogeneous patient populations, rare diseases, and limited clinical data
Communicate statistical concepts, assumptions, limitations, and implications clearly to cross-functional teams
Position Requirements: Ph.D. in Biostatistics/Statistics or equivalent with at least 8+ years’ relevant work experiences or M.S. in Biostatistics/Statistics with at least 10+ years’ relevant experience
Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
Ability to develop innovative/creative statistical/technical solutions to complex problems
Leadership skills in priority evaluation, adapting to changes, conflict resolution, and effective partnership
Ability to work independently, exercise sound scientific judgment, and manage multiple competing priorities
Experience managing CROs, external statistical consultants, and statistical programming vendors
Experience with NDA or other major regulatory submissions
Excellent written and verbal communication skills, including the ability to communicate statistical concepts to non-statistical stakeholders
Experience supporting rare disease or other indications with small patient populations and limited clinical data is preferred
Experience with external control groups, natural history studies, patient registries, or systematic literature reviews is preferred
Must be willing to work onsite at least 4 days a week

Associate Director/Director, Biostatistics

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