Director, Statistical Sciences

Sobi•Waltham, MA

7h•$175,000 - $240,000

About The Position

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.

Requirements

Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent.
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 experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues
Experience of major regulatory submissions and/or previous attendance at meetings with regulatory authorities
Comprehensive knowledge of clinical and pharmaceutical drug development
Sound knowledge of theoretical and applied statistics
Ability to find innovative approaches to trial design and analysis
Sound understanding of the regulatory environment within clinical development
Ability to be the statistical representative from the company at regulatory interactions
Ability to coach less experienced statisticians in all aspects of their role.
Excellent written and oral communication skills
Strategic thinking and influencing skills
Ability to communicate statistical information to non-statisticians
Strong ability to collaborate and contribute in global cross-functional teams
Leadership skills

Nice To Haves

Master of Science (MSc) or PhD in mathematical statistics, statistics or equivalent
Experience working in all phases of clinical development
Extensive experience of regulatory submissions and previous attendance at meetings with regulatory authorities in more than one region, e.g. Europe, US, Japan, and China
Experience of collaboration with statisticians and other functions at CROs around out-sourced clinical studies

Responsibilities

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

Benefits

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
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.