h3Position Purpose: /h3 pThe 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. (There are 2 positions available supporting multiple Therapeutic Areas) /p h3Work Environment: /h3 pb*** This is a hybrid position with a minimum of 3 days onsite in the designated work location weekly. Relocation assistance is not provided. /b /p h3Main Responsibilities: /h3 ul 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. /li liLead 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 /ul h3Minimum Qualifications: /h3 ul 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 /ul h3Competencies: /h3 ul liFamiliarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes /li liAbility to collaboratively work and provide leadership in matrix environment -Strong 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 /ul pThe expected base salary range for this position at the Waltham, MA site is $212,000 - $251,000/yr. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, geographic location, and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. /p p#LI-HYBRID /p #J-18808-Ljbffr
Associate Director, Biostatistics Research Development & Sciences Biostatistics CSL Behring Glattbrugg, Zürich, Switzerland R-282817 Posted on October 29, 2026 Arbeitgeber: CSL
Unser Unternehmen bietet eine dynamische und unterstützende Arbeitsumgebung, die sich auf die Förderung von Innovation und Exzellenz in der analytischen Wissenschaft konzentriert. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen bieten wir zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung, während wir gleichzeitig ein positives und kollaboratives Arbeitsklima pflegen. Unsere Lage in einer hochmodernen Einrichtung ermöglicht es Ihnen, an vorderster Front der pharmazeutischen Forschung zu arbeiten und einen bedeutenden Beitrag zur Verbesserung der Gesundheitsversorgung zu leisten.
