Principal Biostatistician- European Support

2 giorni fa

Roma, Italia Vertex Pharmaceuticals A tempo pieno

Job Description

The Principal Biostatistician will perform advanced scientific statistical analyses within Real World Statistics, with some guidance and mentoring on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Responsibilities:

- Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including the design, development and execution of the technical/statistical infrastructure.
- Possesses an advanced understanding of modern drug discovery and development processes.
- Represents Biostatistics as a member of clinical trial teams, providing input and technical guidance to elicit meaningful and/or productive outcomes.
- With mínimal guidance, authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.
- Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.
- Contributes to external interactions with regulators, payers, review boards, etc.
- Develops statistical section of protocols, including sample size estimates and randomization plans.
- Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review.
- Implements design and analysis methods at the study level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
- Contributes to departmental working group efforts on various advanced technical and operational issues.
- Undertakes new and complex issues with mínimal guidance
- Completes assigned work in a resourceful, self-sufficient manner and creates alternative approaches to achieve desired results if needed.
- Develops breadth of knowledge across related disciplines with a drug developer mindset.

Key Requirements:

- Ph.D. or Master's degree in Statistics or Biostatistics
- In-depth experience with SAS and R statistical software
- Demonstrated understanding of advanced statistical methods used in drug development
- Ability to show critical thinking with logical problem-solving
- Excellent written and verbal communication skills
- Team member who supports others and able to learn from others
- Ability to work in cross functional teams
- Collaborates well with non-statisticians.

Company Information
- Vertex is a global biotechnology company that invests in scientific innovation.
- Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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