Director, Statistical Sciences

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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.

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 products
• is 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 CROs
• is 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.

• Provide leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CRO
• 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 pro‑active 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

Required: Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent.

Desired: Master of Science (MSc) or PhD in mathematical statistics, statistics or equivalent

Required:

• 8 years of experience as a statistician in the pharmaceutical industry
• Previous leadership experience from project and/or line management
• Extensive experience working in phase II, III and IV programs and/or studies
• Extensive…