Associate Director, Biostatistics (2)

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.

Main Responsibilities:

• 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.

Education and Experience:

• 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.

Competencies:

• 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.
• Biostatistics and Statistical Programming Operations.