Principal Biostatistician

**Summary**

The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for discovery, manufacturing, research, development, and/or marketed product needs with mínimal supervision. The role supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents Statistics for cross-functional teams or working groups.

**Core Competencies, Responsibilities and Accountabilities**

**Expertise**: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.

**Quality and Compliance**: Complies with organization and company standard operating procedures in timely fashion, such as training. Understands and aligns with relevant regulatory guidance. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, etc. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.

**Drug Development**: Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Takes a lead in providing statistics support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications.

**Disease Area Knowledge**: Demonstrates knowledge for at least one relevant disease area/target. Knowledge of Immunology, Oncology is needed.

**Innovation**: Suggests and performs the evaluation of alternative or innovative approaches to statistical methods or business processes.

**Complexity**: Works on increasingly more complex programs after mastering standard ones. Proactively identifies complexity in terms Scientific, Statistical, Health Authority, Operational, and Partnership issues.

**Communication**: Should have very good written, oral, and interpersonal communication skills. Demonstrated ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners.

**Programming**: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.

**Education and Experience Requirements**
- Ph.D. in Statistics or related field with minimum 3 years relevant experience, or Master’s in Statistics or related field with minimum 5 years of relevant experience.
- Proficient in SAS or R programming.
- Good written, oral, and interpersonal communication skills.
- Ability to work independently.
- Demonstrated ability to work in interdisciplinary contexts outside statistics.