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Company

Sobi - Swedish Orphan Biovitrum AB (publ) · 1 day ago

Director of Biostatistics

Denver, CO

Full-time

Remote

Director/Executive

8+ years exp

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Responsibilities

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.

Accountable for the overall quality and the timely delivery of the statistical analyses for the 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.

Provide 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.

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.

Responsible for coaching and developing less experienced statisticians.

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.

Participate in the review and approval of study essential documents in the role as a project-independent statistician.

Qualification

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Statistical analysisClinical developmentRegulatory submissionsStatistical techniquesLeadership experienceProject managementScienceMaster of ScienceCollaboration with CROsCoachingInnovative trial designStatistical representationSOP developmentStrategic thinking

Required

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

Excellent writing and oral communication in English

Preferred

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