Job Summary

This position supports early phase development and leads complex studies up to POC (proof of concept), including dose-escalation, dose-expansion, and dose-optimization studies, in study design, statistical analysis, interpretation, and reporting of results. This position contributes to drug development plans and Health Authority documents while independently providing statistical leadership for assigned studies. This position serves as the main statistical contact for assigned studies and collaborates with cross-functional study and project teams to solve complex study problems. The position provides scientific oversight of delegated CRO statistical activities while retaining accountability for the quality and timeliness of statistical deliverables. This position partners closely with Early Development study and project teams, including Clinical Development, Clinical Science, Clinical Pharmacology, Precision Medicine, Translational Science, Clinical Operations, and other relevant functions, to support study execution, data interpretation, and development decision-making.

Responsibilities

• Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex early phase studies, including dose-escalation, dose-expansion, and dose-optimization design; protocol development; CRF review; SAP and analysis specification development; statistical analysis quality review; results interpretation; and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides statistical guidance to study and project teams and contributes to the evaluation and integration of emerging safety, tolerability, efficacy, pharmacokinetic/pharmacodynamic, and biomarker data to support dose escalation, dose selection, cohort expansion, and development decisions; collaborates closely with data management and statistical programming to ensure high-quality data and outputs.

• Drug Development Strategy: Provides statistical input to early development plans and decisions, including dose and schedule selection, cohort expansion, proof-of-concept assessment, and advancement decisions, to ensure study designs are scientifically sound, fulfill regulatory requirements, and support the evaluation for the pre-specified drug product profile.

• CRO / Vendor Oversight: Provides scientific and technical oversight of delegated CRO/vendor statistical activities and ensures deliverables meet quality, compliance, and timeline expectations. Reviews CRO/vendor proposal and budget.

• Global Health Authority Support: Contributes to the statistical content of global Health Authority documents and responses for assigned studies and may participate in Health Authority meetings or teleconferences to support the statistical rationale for study design, dose optimization, analysis, and decision criteria.

• Global BDM Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

Qualifications

Education Qualifications
Master's Degree in statistics or biostatistics required and PhD in statistics or biostatistics preferred

Experience Qualifications
8+ Years of relevant experience in the pharmaceutical industry with a masters degree required or
5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred
Minimum 2 years of experience supporting Early Phase drug development studies, including dose-escalation, dose-expansion, dose-optimization, or proof-of-concept studies preferred. preferred
- Strong written and verbal communication skills - Proficiency in SAS and/or R required. required
- Experience applying statistical methodologies relevant to Early Phase development, including Bayesian methods, adaptive designs, dose-finding approaches, modeling and simulation, and decision-making statistical frameworks such as futility assessment preferred. - Demonstrated ability to provide real-time statistical consultation and recommendations in fast-paced, cross-functional discussions. Demonstrated ability to evaluate and discuss multiple statistical design options and support the selection of fit-for-purpose development strategies. preferred


Travel Requirements
Ability to travel up to 10% of the time.