Principal Statistical Scientist

**Company 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.

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.
- Ability to mentor and coach junior staff.

**Languages**

**_ Required: _**
- Excellent writing and oral communication in English

**Additional Information**
All your information will be kept confidential according to EEO guidelines.