Sr. Advisor, Clinical Biostatistician

Job Description

Remote High Level Advisory work. Not 40 hours per week. As needed, 10-20 hours per week until close to launch

Early phase: Clinical Development StrategyProvide statistical input into early clinical development plans.

Design Phase I, First-in-Human (FIH), SAD/MAD, dose-escalation, food-effect, DDI, proof-of-concept, and Phase II studies.

Develop adaptive and model-informed trial designs where appropriate.Support dose selection and go/no-go decision-making.

Protocol and Design DevelopmentAuthor statistical sections of protocols.Determine sample size and operating characteristics.

Develop randomization schemes and statistical methodologies.Evaluate innovative designs such as Bayesian, adaptive, and seamless Phase I/II studies.Statistical DeliverablesAuthor Statistical Analysis Plans (SAPs).

Review TFL (Tables, Figures, Listings) specifications.Oversee statistical programming deliverables.Ensure quality and regulatory compliance of analyses.

Data Review and InterpretationParticipate in ongoing safety review and dose-escalation committees.

Perform interim analyses and data monitoring activities.Interpret PK, PD, biomarker, and exploratory efficacy data.Regulatory SupportContribute to regulatory meeting packages (FDA, EMA, PMDA, etc.).

Support briefing documents and responses to health authority questions.Cross-Functional LeadershipCollaborate with Clinical Pharmacology, Translational Medicine, Biometrics, and Medical Monitoring teams.

Mentor junior statisticians and statistical programmers. Late Phase Project Lead Statistician (Phase III/IV)

Primary Responsibilities

Program-Level Statistical Leadership

Lead statistical strategy across pivotal Phase III and post-marketing programs.

Ensure alignment of statistical plans with regulatory requirements and business objectives.

Drive endpoint strategy and estimand framework implementation.Study Design and PlanningDesign confirmatory efficacy and safety trials.

Develop sample size justifications and multiplicity strategies.

Define interim analyses and Data Monitoring Committee support plans.

Provide risk assessment and mitigation for statistical issues.

Regulatory Submission SupportLead statistical contributions to NDA, BLA, MAA, and supplemental submissions.

Author statistical sections of integrated summaries (ISS/ISE).Participate in regulatory inspections and health authority interactions.Present statistical findings during agency meetings.

Analysis and ReportingOversee SAP development and execution.Review CSR statistical content.

Ensure integrity and quality of all statistical outputs.Interpret efficacy, safety, and patient-reported outcome results.Vendor and CRO Oversight

Manage outsourced statistical activities.Ensure delivery against timelines, quality standards, and budget expectations.Leadership and Governance

Represent Statistics on project teams and governance committees.Influence development strategy and key program decisions.

Pay: $250.00 – $300.00 per hour

Work Location: Remote