Associate Director, Biostatistics
CSL
full-time
Posted on:
Location Type: Hybrid
Location: Glattbrugg • Switzerland
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Job Level
About the role
- 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.
- Provide statistical thought partnership for innovative study design and clinical development plans.
- Provide for project-wide planning of analyses; quality and timely delivery of interim and final results.
- Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).
- Manage outsourcing operations or work with internal statistical programmers within the responsible program.
Requirements
- PhD or MS in Biostatistics, Statistics or related field
- 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 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
- 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.
Benefits
- CSL benefits include health insurance,
- retirement plans,
- paid time off,
- flexible working arrangements,
- professional development opportunities.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
BiostatisticsStatisticsstatistical methodologiesclinical trialsdata analysisregulatory submissionsstatistical leadershipadvanced statistical methodologiesSASR
Soft Skills
interpersonal skillscommunication skillsleadershipcollaborationinfluenceproject managementthought partnershipinnovation
Certifications
PhDMS