Hybrid Biostatistics Lead, Clinical Development

CSL Plasma; Waltham (MA); Hybrid; USD 212,000 - 251,000; Full time

Job summary

CSL Plasma seeks an Associate Director, Biostatistics, to lead statistical strategies across clinical development programs and regulatory submissions. The role includes collaborating with cross-functional teams and guiding study design, analyses, and reporting, in a hybrid work setting.

The position requires extensive experience in drug development, leadership in regulatory submissions, and strong expertise in SAS/R and advanced statistical methods. Regulatory interactions are part of the remit.

Qualifications

• PhD with 8+ years 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.

Responsibilities

• Lead full scope of Biostatistics conduct for the responsible program; define statistical strategy.
• Influence and contribute to clinical development plans with cross-functional teams.
• Lead planning and study execution with study executive and development teams.
• Provide statistical thought partnership for innovative study design and go/no-go criteria.
• Ensure timely delivery of interim and final results with integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities (FDA/EMA/PMDA).
• Manage outsourcing or CRO/FSP data work; ensure quality of deliverables.
• Support improvement initiatives within the department and industry.
• Prepare abstracts, posters, and reports communicating results to stakeholders.

Skills

Statistical leadership

SAS/R proficiency

Communication in English

Regulatory submissions knowledge

Education

PhD required

MS degree considered

Tools

CRO management experience

Job description

CSL Plasma seeks an Associate Director, Biostatistics, to lead statistical strategies across clinical development programs and regulatory submissions. The role includes collaborating with cross-functional teams and guiding study design, analyses, and reporting, in a hybrid work setting.

The position requires extensive experience in drug development, leadership in regulatory submissions, and strong expertise in SAS/R and advanced statistical methods. Regulatory interactions are part of the remit.