Associate Director, Biostatistics

CSL; Maidenhead; Hybrid; GBP 120,000 - 190,000; Full time

Job summary

CSL in Maidenhead, UK, seeks an Associate Director, Biostatistics to lead the statistical contribution across a clinical development program. You will define strategies for trials and regulatory submissions, ensuring deliverables meet regulatory expectations and quality standards.

You will lead interactions with regulators, oversee internal and CRO statistical teams, and guide innovative study designs while communicating results to diverse stakeholders.

Qualifications

• PhD or MS in Biostatistics, Statistics or related field.
• PhD with extensive drug development experience or MS with extensive experience.
• Experience providing statistical leadership at compound/indication level.
• Leadership in facilitating regulatory submissions and development strategy.
• Experience with CROs or internal delivery of statistics projects.
• Familiarity with regulatory guidance and CDISC standards.

Responsibilities

• Lead full scope of Biostatistics conduct for the program.
• Define statistical strategy for study design and analysis.
• Lead planning of analyses and timely reporting for submissions.
• Represent Biostatistics in regulatory interactions (FDA/EMA).
• Manage outsourcing or CRO/FSP deliverables with quality.
• Support improvement initiatives within the department.
• Prepare abstracts, posters, and reports for stakeholders.

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

Job description

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program.

1. 1 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
2. 2 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.
3. 3 Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
4. 4 Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
5. 5 Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
6. 6 Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
7. 7 Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
8. 8 Support or lead improvement initiatives within the department, organization and/or pharma industry.
9. 9 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.

Qualifications

• Education: 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 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

The role can be based in Zurich (Switzerland), King of Prussia (USA), Waltham (USA) or Maidenhead (UK).

This role requires on-site presence three days per week.