Senior Statistical scientist

  • Sobi
  • Basel, BS, Switzerland
  • 13/02/2023
Full time Data Science Business Intelligence Statistics Biostatistics

Job Description

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.

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

Location

The position will be based in Basel, Switzerland.

Reporting to

Head of Observational Research

Recruitment contact & how to apply

For questions contact HR responsible for this recruitment XXXX XXXX
If you are interested in applying for this position, please submit your CV and cover letter through the apply button above.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.