Senior Statistical Scientist

**Senior Statistical Scientist**

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

**Role & Function**

The Senior Statistical Scientist will provide strategic statistical support and advice to teams conducting observational research across functions and throughout all phases in drug development. In addition, this role will be the main provider of statistical expertise within the Observational Research Unit supporting all staff. Furthermore, the Senior Statistical Scientist will efficiently work with third party vendors. The Senior Statistical Scientist will also contribute to an increased understanding of the analysis of observational data in the company. The Senior Statistical Scientist observational research is typically taking the role as study statistician in studies of observational design but may also take other roles as appropriate.

**Key Responsibilities/Scope of the Job**
Including but not limited to the following:

- Responsible for the overall quality and the timely delivery of the statistical analyses for the assigned indication or program
- Responsible for providing statistical expertise to study teams, in particular for the analysis of observational data and in charge of monitoring the work of the third party vendor in areas of statistics and quality aspects of observational data
- Aim at increasing the understanding of data analysis in observational studies, including studies of comparative effectiveness research (CER), in the companyProvide leadership and project coordination to the statisticians working in the program, including in-house consultants and statisticians at CROs
- Provide leadership to in-house consultants and statisticians at third party vendors working in the assigned observational studies and guidance to the project teams in designing innovative studies to meet project objectives and regulatory requirements
- Develops Statistical Analysis Plans for observational studies
- Provide statistical input on a study level: contributes to establishment of Study protocols, Statistical Analysis Plans, as well as study report prototypes, i.e. Tables, Figures and Listings and ensure that the interpretation and presentations of results and the conclusions in the Study Report are scientifically justified by the study results
- Provide statistical and programming support for in-house reporting, simulations and exploration of data
- Collaborate with internal statisticians and other functions in the department to drive best practices in observational research and implement new initiatives
- Stay informed of developments in new statistical methodology in observational research and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings. In particular this concerns the design and analysis of comparative effectiveness research (CER).
- Participate in preparing responses to regulatory questions
- Contributes to the development of SOPs as relevant and contribute with analyses/presentations and the writing of publications and abstracts, in accordance with the publication strategy for the project.
- Provide strategic guidance on regulations and changes in assigned countries
- Support interactions with Health Authorities in assigned countries

**Qualifications**
- Education; Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent. Desired: Master of Science (MSc) or PhD in mathematical statistics, statistics or equivalent
- Minimum 5 years of experience as a statistician in the pharmaceutical industry
- Previously working as a study statistician or equivalent
- Experience working in more than one phase of clinical development
- Experience of statistical programming in SAS
- Excellent writing and oral communication in English
- Desired; experience working in all phases of clinical development, experience of regulatory submission and defense activities, experience of regulatory interactions, experience of clinical program and study design and data analysis in using a variety of designs and statistical techniques and experience of collaboration with statisticians and other functions at CROs in the area of out-sourced clinical studies.

**Personal Attributes**

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 comm