Ph3Associate Director, Biostatistics /h3pThe 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. /ph3Responsibilities /h3ulliLead 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. /liliInfluence 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. /liliProvide statistical thought partnership for innovative study design and clinical development plans, including Go‑No Go criteria and probability of technical success calculations. /liliProvide for project‑wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions. /liliRepresent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA). /liliBe responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. /liliManage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP. /liliSupport or lead improvement initiatives within the department, organization and/or pharma industry. /liliPrepare 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. /li /ulh3Qualifications /h3ulliEducation: PhD or MS in Biostatistics, Statistics or related field. /liliPhD with 8 years of experience or MS with 11 years of experience in drug development. /liliExperience providing statistical leadership at compound/indication level. /liliDemonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full‑) clinical development strategy. /liliSolid experience in applications of advanced statistical methodologies. /liliLeading roles in regulatory submissions. /liliExperience in interactions with major regulatory authorities preferred. /liliExperience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred. /liliTrack record of innovation preferred. /li /ulh3Competencies /h3ulliFamiliarity with regulatory guidance and interactions. /liliBroad knowledge of clinical development and processes. /liliAbility to collaboratively work and provide leadership in matrix environment. /liliStrong interpersonal and communication skills (verbal and written in English). /liliGood working knowledge of SAS and/or R. /liliExpertise in a range of statistical methodologies. /liliDemonstrated use of innovative / creative methodology for analysis of clinical data. /liliFamiliarity with relevant regulatory guidance documents. /liliExpertise in CDISC, statistical programming, and/or data standards. /li /ulh3Locations /h3ulliZurich (Switzerland) /liliKing of Prussia (USA) /liliWaltham (USA) /liliMaidenhead (UK) /li /ulpThe role requires on‑site presence three days per week. /ppEqual Opportunity Employer. CSL 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 /p /p #J-18808-Ljbffr