Principal Statistical Scientist

Sobi

Basel, Switzerland

Job Description

Provide experienced statistical, scientific and strategic input to all clinical study activities, including protocol design and publications with a focus on observational research.

Will also contribute to across study activities such as clinical development planning, regulatory (PASS and ODDs) and reimbursement requests or submissions, medical affairs and marketing activities or other as appropriate

The Principal Statistical Scientist is typically taking the role of Study Statistician for multiple studies or complex studies but may also work as a Program Statistician or Product statistician for smaller products.

Key Responsabilities

is responsible for the quality and the timely delivery of the statistical analysis plan, the quality of statistical analyses and interpretation of study results
is responsible for providing statistical expertise to study teams
is responsible for monitoring the work of the CRO in areas of statistics, programming and quality of data
is responsible for providing guidance and leadership to CRO statisticians in the assigned studies
provides leadership to in-house consultants and statisticians at CRO working in the assigned studies
supports the Product Statistician in designing innovative studies to meet project objectives and regulatory requirements
develops Statistical Analysis Plans for studies and regulatory submissions
provides statistical input on a study level: contributes to establishment of Study protocols, Statistical Analysis Plans, CRF 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 Clinical Study Report are scientifically justified by the study results
provides programming support for in-house reporting, simulations and exploration of data
contributes to the development of CSRs
provides statistical input in the evaluation and collaboration with CRO suppliers
collaborates with internal statisticians and other functions in the department to drive best practices and implement new initiatives
stays informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.
contributes to the development of SOPs as relevant.

Qualifications

Education/Learning Experience

Required: MSc + 8 years, PhD + 5 years; Statistical science
Desired: MSc + 8 years, PhD + 5 years; Statistical Science and Epidemiology

Work Experience

Sound knowledge of clinical drug development
Experience working in several phases of clinical development including medical affairs and post marketing
Experience of clinical program and study design and data analysis in using a variety of designs and statistical techniques
Experience with post marketing activities, such as publication strategies, reimbursement analyses.
Sound understanding of the regulatory environment within clinical development and can support regulatory activities, interactions and submissions
Ability to be the statistical representative from the company at regulatory interactions
Ability to coach less experienced statisticians in all aspects of their role.
Ability to learn and use innovative or complex approaches to trial design and analysis and SME for some statistical methodologies. Focus on observational studies.

Personal Attributes

Strategic thinking and influencing skills
Ability to communicate highly complex statistical information and concepts to non-statisticians and in response to regulatory questions.
Considered a subject matter expert in relevant statistical methodology and can quickly learn new methodologies as needed.
Ability to mentor and coach junior staff.