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CSL · 1 month 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, Biostatistics, leads the statistical contribution to clinical development programs, providing 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

Statistical leadershipAdvanced statistical methodologiesRegulatory submissionsBiostatistics expertiseSASRCRO managementClinical development knowledgeInnovative methodologyInterpersonal skillsCommunication skills

Required

PhD with 8 years of experience or MS with 11 years of experience in drug development

Experience providing statistical leadership at compound/indication level

Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy

Solid experience in applications of advanced statistical methodologies

Leading roles in regulatory submissions

Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes

Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English)

Good working knowledge of SAS and/or R

Expertise in a range of statistical methodologies

Demonstrated use of innovative / creative methodology for analysis of clinical data

Familiarity with relevant regulatory guidance documents

Expertise In CDISC, statistical programming, and/or data standards

Biostatistics and Statistical Programming Operations