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CSL · 6 hours ago

Associate Director, Biostatistics

King of Prussia, PA

Full-time

Onsite

Lead/Staff, Director/Executive

8+ years exp

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. The Associate Director of Biostatistics leads the statistical contributions to clinical development programs, ensuring the application of appropriate statistical methodologies and strategies for clinical trials and regulatory submissions.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area

Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions

Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews

Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents

Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations

Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions

Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)

Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents

Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP

Support or lead improvement initiatives within the department, organization and/or pharma industry

Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge

Qualification

PhD in BiostatisticsStatistical leadershipAdvanced statistical methodologiesRegulatory submissionsSASRClinical development knowledgeCRO managementInnovative methodologyInterpersonal skillsCommunication skills