Associate Director, Biostatistics

CSL

Associate Director leading statistical contributions to clinical development for CSL Behring. Involves managing biostatistics, regulatory submissions, and innovative study design.

Posted 6/4/2026full-timeMaidenhead • Massachusetts, Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
Experience in interactions with major regulatory authorities preferred
Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
Track record of innovation preferred
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

Benefits

Comp & perks

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

statistical methodologiesstatistical programmingCDISCdata standardsadvanced statistical methodologiesclinical development strategyregulatory submissionsprobability of technical success calculationsquantitative evaluationinterim and final results analysis

Soft Skills

leadershipinterpersonal skillscommunication skillscollaborationinnovationproject managementstrategic thinkingproblem-solvingstakeholder engagementmatrix environment leadership

Certifications

PhD in relevant fieldMS in relevant field