Biostatistics Strategy Lead - Clinical Development

CSL; Zürich; Hybrid; CHF 175,000 - 207,000; Full time

Job summary

CSL is seeking an Associate Director, Biostatistics, to lead statistical contributions across clinical development programs. You will define strategy, supervise analyses, and interact with regulators including FDA/EMA.

The hybrid role requires a minimum of 3 onsite days per week at the Waltham site. Responsibilities include leading planning and execution of analyses for submissions, mentoring statisticians, and collaborating with cross-functional teams to ensure timely, high-quality

Qualifications

• PhD with 8 years of drug development experience or MS with 11 years.
• Experience providing statistical leadership at compound/indication level.
• Leading roles in regulatory submissions and interactions with authorities.

Responsibilities

• Lead full scope of Biostatistics conduct for the program and define statisti cal strategy.
• Influence clinical development plans and collaborate with cross-functional teams.
• Lead planning and execution of analyses for regulatory submissions.
• Provide statistical partnership for innovative study design and go/no-go criteria.
• Ensure timely, quality interim and final results and regulatory reporting.

Skills

Statistical leadership

SAS/R

Regulatory interactions

Clinical development strategy

Regulatory submissions

CRO management

Education

PhD in biostatistics/Statistics

MS in statistics/biostatistics

Tools

SAS

R

Job description

CSL is seeking an Associate Director, Biostatistics, to lead statistical contributions across clinical development programs. You will define strategy, supervise analyses, and interact with regulators including FDA/EMA.

The hybrid role requires a minimum of 3 onsite days per week at the Waltham site. Responsibilities include leading planning and execution of analyses for submissions, mentoring statisticians, and collaborating with cross-functional teams to ensure timely, high-quality