Senior Biostatistician

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Job description

Job Description

General Summary:

The Senior Biostatistician II will perform scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with guidance and mentoring on new and complex issues. The incumbent will complete assigned work in a resourceful manner and create alternative approaches to achieve desired results. The incumbent will develop a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties and Responsibilities:

* Within assigned area, designs, develops and executes the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational studies, or real world data (RWD) investigations, including related areas/activities.
* Participates in regular Study Execution Team (SET) team meetings as the functional representative.
* Works under supervision to author study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells, and presentation to Statistical Review Forum (SRF).
* Plans and conducts Cross-functional Data Review (xFDR) , Key Results Memo (KRM), and Data Dissemination Plan (DDP) in order 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. Provides input into programming specifications and review.
* Develops statistical section of protocols, including sample size estimates and randomization plan.
* Contributes to clinical study reports (CSRs) and related processes. May author or co-author methodological or study-related publications and posters.
* Implements design and analysis methods at the study level and participates in SRF discussions of studies assigned to others.
* Contributes to departmental working group efforts on various technical and operational issues.
* Seeks guidance and mentoring on new and complex issues
* Completes assigned work in a resourceful manner and creates alternative approaches to achieve desired results if needed.
* Develops a basic knowledge of related disciplines with a drug developer mindset.

Knowledge and Skills:

* Competence with SAS and R statistical software
* Demonstrated understanding of statistical methods used in drug development
* Ability to show critical thinking with logical problem-solving
* Excellent written and verbal communication skills
* Excels in a team environment
* Collaborates well with non-statisticians

Education and Experience:

* Ph. D. or master's degree in Statistics or Biostatistics.
* Typically requires 3 years of experience for those with a master's degree or the equivalent combination of education and experience.

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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at .