Full-Time Director of Biostatistics

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 specialized areas and/or line functions (e.g. drug safety, clinical pharm) to maximize the benefit-risk of Sobi products.

Product Statistician:

• Accountable for the overall quality and the timely delivery of the statistical analyses for assigned products.
• 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.
• 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 CROs.
• 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 CROs
• Provide statistical and strategic input into the establishment of a focused, aligned and achievable Target Product Profile (TPP) and Target Labels
• Provide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP) ensuring alignment with the TPPs and Target Label
• Provide statistical and strategic input to relevant documents in regulatory submissions, e.g. eCTD
• Take a proactive role in designing innovative studies and programs, including Go/No Go criterion and associated risk levels, to meet project objectives and regulatory requirements
• Approve and sign CSPs, including the statistical content
• Approve Statistical Analysis Plans for studies and regulatory submissions
• Approve and sign CSRs, including the statistical analysis and clinical interpretation of study data
• Participate in preparing responses to regulatory questions
• Provide statistical and strategic input into other regulatory documentation, e.g. CSP, CSR, IB, PSUR and RMP
• Participate in developing the publication strategy as a member of the publication team
• Contribute to the writing of publications and abstracts, in accordance with the publication strategy for the project, as applicable
• Ensure high quality statistical support for projects through the evaluation of CRO suppliers, and provide input into outsourcing strategy and processes
• Collaborate with internal statisticians to drive best practices and implement new initiatives
• Stay 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 relevant
• As SDRF statistician, participate in the review and approval of study essential documents in the role as a project-independent statistician

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