Statistical Science Director provide highly experienced statistical, scientific and strategic support to the clinical and regulatory strategies across all phases of drug development, in-licensing opportunities, pre-clinical development, marketing activities, other specialised areas and/or line functions (e.g. drug safety, clinical pharm) to maximise the benefit-risk of Sobi products.The Statistical Science Director is typically taking the role as the Product Statistician.The Product Statistician:is accountable for the overall quality and the timely delivery of the statistical analyses for the assigned productsis accountable for all statistical aspects within assigned products providing statistical, scientific and strategic expertise to quantify the benefit-risk value and uncertainty of the emerging product profile throughout all phases of the drug development process in compliance with Sobi SOPs and regulatory requirements/guidelines.is accountable for leading the statistical thinking and contributions to the creation and development of TPP/TPC, Target Label and Clinical Development Plans as well as to the Regulatory and Commercial Strategies for Sobi products.provides leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CROsis accountable for the statistical content in the CSP and CSR  The Statistical Science Director is qualified for membership of the Study Document Review Forum (SDRF) and may also participate in in-licensing projects or work in other roles as appropriate.The Statistical Science Director is responsible for coaching and developing less experienced statisticians.Product Statistician:Provide leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CROProvide statistical and strategic input into the establishment of a focused, aligned and achievable Target Product Profile (TPP) and Target LabelsProvide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP) ensuring alignment with the TPPs and Target LabelProvide statistical and strategic input to relevant documents in regulatory submissions, e.g. eCTDTake a pro-active role in designing innovative studies and programs, including Go/No Go criterion and associated risk levels, to meet project objectives and regulatory requirementsApprove and sign CSPs, including the statistical contentApprove Statistical Analysis Plans for studies and regulatory submissionsApprove and sign CSRs, including the statistical analysis and clinical interpretation of study dataParticipate in preparing responses to regulatory questionsProvide statistical and strategic input into other regulatory documentation, e.g. CSP, CSR, IB, PSUR and RMPParticipate in developing the publication strategy as a member of the publication teamContribute to the writing of publications and abstracts, in accordance with the publication strategy for the project, as applicableEnsure high quality statistical support for projects through the evaluation of CRO suppliers, and provide input into outsourcing strategy and processesCollaborate with internal statisticians to drive best practices and implement new initiativesStay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.Contribute to the development of SOPs as relevantAs SDRF statisticianParticipate in the review and approval of study essential documents in the role as a project-independent statistician
