Associate Director, Biostatistics

CSL Plasma•Waltham, MA

About The Position

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. CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, they discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. They use three strategic scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Their parent company, CSL, employs 32,000 people and delivers lifesaving therapies to people in more than 100 countries.

Requirements

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
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

Nice To Haves

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

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

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