Associate Director, Biostatistics

ppThe 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. /p ol liLead 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 /li liInfluence 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. /li liProvide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations. /li liProvide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions. /li liRepresent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA) /li liBe responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. /li liManage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP. /li liSupport or lead improvement initiatives within the department, organization and/or pharma industry. /li liPrepare 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 /ol h3Qualifications /h3 ul liEducation: PhD or MS in Biostatistics, Statistics or related field /li liPhD with 8 years of experience or MS with 11 years of experience in drug development /li liExperience providing statistical leadership at compound/indication level /li liDemonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy /li liSolid experience in applications of advanced statistical methodologies /li liLeading roles in regulatory submissions /li liExperience in interactions with major regulatory authorities preferred /li liExperience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred /li liTrack record of innovation preferred /li liFamiliarity with regulatory guidance and interactions /li liBroad knowledge of clinical development and processes /li liAbility to collaboratively work and provide leadership in matrix environment /li liStrong interpersonal and communication skills (verbal and written in English) /li liGood working knowledge of SAS and/or R /li liExpertise in a range of statistical methodologies /li liDemonstrated use of innovative / creative methodology for analysis of clinical data /li liFamiliarity with relevant regulatory guidance documents /li liExpertise in CDISC, statistical programming, and/or data standards /li /ul pThe role can be based in Zurich (Switzerland), King of Prussia (USA), Waltham (USA) or Maidenhead (UK). /p pThis role requires on-site presence three days per week. /p /p #J-18808-Ljbffr