Senior Manager Biostatistics (HTA) / HF

Job Description:

Summary / purpose of the position

• The Senior Biostatistician for Health Technology Assessments (HTA) is an Ipsen Global Biometry biostatistician supporting the development of HTA, in collaboration with Ipsen Health Economics and Outcomes Research (HEOR) and Global Value and Access teams.
• He/She is responsible for the discussion and implementation of rigorous, informative and when appropriate, innovative statistical models, and analysis methodologies that optimally address the research objectives. This position supports all Ipsen therapeutic areas.
• He/She is responsible for designing, implementing, and reporting in a quality, timely and accurate manner, the statistical processes in clinical trials, applying state of the art concepts and tools to the interpretation of clinical trial data so that the evaluation of such data will withstand interrogation and examination by payer bodies.
• He/She oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality, budget, and timelines).

Main responsibilities / job expectations

Related to study activities

• Conduct exploratory statistical analyses of Ipsen clinical trial data in support of HTA objectives
• Contribute to authoring of Global Value and Access deliverables (e.g. Global Value Dossiers, Orphan Drug Designation submissions) and assist in evidence synthesis and economic modeling
• Provide expert statistical advice to address questions from local country authorities in the reimbursement review process
• Provide statistical input for selection and evaluation of external vendors and take responsibility for ensuring that the Service Provider statistical deliverables meet project specifications, and that they are produced to defined quality, content and timetable standards, and to liaise with the Purchasing Manager, to facilitate the achievement of timely, relevant, robust contracts and schedules of works.
• Plan, schedule and track all statistical activities, to ensure high quality, timely and accurate completion of statistical deliverables.
• Manage the Statistical input to the reimbursement review process, addressing payer questions in a timely technically sound and clearly presented manner.
• Develop Statistical processes within the Ipsen Group by working with other statistician colleagues (i.e. Modelling and Simulation).
• Develop, implement or advise on appropriate new statistical developments by keeping abreast of current issues and developments in statistical theory and application.
• Maintain a good network of contacts with outside bodies relevant to clinical statistics, both within the EU and North America.
• Any other activity which may be reasonably required from time to time.
• Complete all the above activities within the framework and in compliance with RD SOPs and other documentation in force within the Ipsen.

Specifics of Position

• Ability to manage projects: plan activities and tasks, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics and communicate efficiently with external vendors as well as internal partners
• Ability to produce high quality, accurate work to meet deadlines
• Ability to interact well with staff of differing disciplines
• Ability to mentor colleagues in development of statistical thinking
• Well-developed time management, communication, presentation, analytical and interpersonal skills
• Responsible, flexible and accountable with a pro-active approach
• Expert knowledge and experience using R and SAS and other statistical software

EHS responsibilities

• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements
• Participate in mandatory EHS training

Knowledge, abilities experience

Education / Certifications:

MS/PhD in statistics or biostatistics or related field

Experience:

Ideal: PhD with 4 years of experience in a similar position. Good experience of participating in selection and management of external vendors

Minimum: MS with 7 years of experience as statistician in clinical research

Languages:

English

Key Technical Competencies Required

• Advanced knowledge of Statistics and the drug development process applied to clinical studies
• Advanced understanding of statistical methods used in evidence synthesis (e.g. network meta-analysis, indirect treatment comparisons) to clinical trial data
• High knowledge of international standards (ICH, GCP, CDISC ) and regulatory submission experience (FDA, EMA, etc.)
• Proficiency with statistical software tools such as SAS, R, S-Plus, EAST, JMPC, etc. High level of expertise of oversight and management of external vendors
• Strong attention to detail, excellent communication skills, good interpersonal skills, and cross-cultural understanding and sensitivity
• Ability to see the big picture while keeping an eye on details
• Independent problem-solving and self-direction skills
• Ability to manage multiple complex projects and assess resource needs

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