Sr. Biostatistician II

Job Description

General Summary:

The Senior Biostatistician II will perform scientific statistical analyses in support of the companys 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 masters degree in Statistics or Biostatistics.
• Typically requires 3 years of experience for those with a masters degree or the equivalent combination of education and experience.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

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 persons 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