Senior Statistical Scientist Observational Research

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.

Job Description

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.

The Senior Statistical Scientist Observational Research:

• is responsible for the quality and the timely delivery of the statistical analysis plan, the quality of statistical analyses and interpretation of study results in observational studies
• is responsible for providing statistical expertise to study teams, in particular for the analysis of observational data
• is responsible for monitoring the work of the third party vendor in areas of statistics and quality aspects of observational data
• is responsible for increasing the understanding of data analysis in observational studies, including studies of comparative effectiveness research (CER), in the company
• provides leadership to in-house consultants and statisticians at third party vendors working in the assigned observational studies
• provides guidance to the project teams in designing innovative studies to meet project objectives and regulatory requirements
• develops Statistical Analysis Plans for observational studies
• provides 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
• ensures that the interpretation and presentations of results and the conclusions in the Study Report are scientifically justified by the study results
• provides statistical and programming support for in-house reporting, simulations and exploration of data
• provides statistical input in the evaluation and collaboration with third party vendors
• collaborates with internal statisticians and other functions in the department to drive best practices in observational research and implement new initiatives
• stays 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).
• contributes to the development of SOPs as relevant

The Senior Statistical Scientist Observational Research may also

• Participate in preparing responses to regulatory questions
• Contribute with analyses/presentations and the writing of publications and abstracts, in accordance with the publication strategy for the project.

Qualifications

Education/Learning Experience

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

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

Work Experience

Required:

• 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

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
• Experience of collaboration with statisticians and other functions at CROs in the area of out-sourced clinical studies

Skills/Knowledge

Required:

• 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.

Desired:

• Knowledge of clinical and pharmaceutical drug development
• Experience of statistical programming in SAS and other statistical software
• Good understanding of CDISC
• Experience of collaboration with CROs in the area of out-sourced clinical studies
• Ability to find innovative approaches to trial design and analysis
• Sound understanding of the regulatory environment within clinical development
• Experience of analysis of observational data, in particular comparative effectiveness studies.

Personal Attributes

Required:

• 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

Additional Information

In addition, you must demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.