Job Title

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinicaldevelopment program. The AD provides statistical strategies for the clinical trials and regulatorysubmissions, and is accountable for the statistical deliverables within the program.1 Lead full scope of Biostatistics conduct for the responsible program within a therapeuticarea. Define statistical strategy and ensure appropriate statistical methodologies applied tostudy design and data analysis for clinical trials and regulatory submissions2 Influence and contribute to clinical development plans, collaborate with cross-functionalteam for governance reviews. Lead statistical strategy for planning and study execution(member of Study Executive Team, Clinical Development Team) and quantitative evaluationto clinical trials, regulatory submissions, and related documents.3 Provide statistical thought partnership for innovative study design and clinical developmentplans, including Go-No Go criteria and probability of technical success calculations.4 Provide for project-wide planning of analyses; quality and timely delivery of interim and finalresults, including integrated analyses for submissions.5 Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)6 Be responsible for interpreting analysis results and ensuring reporting accuracy in studyreports and regulatory documents.7 Manage outsourcing operations or work with internal statistical programmers within theresponsible program. Ensure timeliness and quality of deliverables by CRO/FSP.8 Support or lead improvement initiatives within the department, organization and/or pharmaindustry.9 Prepare abstracts, posters, oral presentations and written reports to effectivelycommunicate results of clinical programs and studies to internal and external stakeholdersand colleagues with varying levels of clinical research knowledge. Education PhD or MS in Biostatistics, Statistics or related fieldExperience -PhD with 8 years of experience or MS with 11 years of experience in drugdevelopment-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) ormanaging internal deliveries preferred-Track record of innovation preferredCompetencies -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 standardsAbout CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit and CSL Plasma at BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSLAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit