Real World Senior Biostatistician II (Hybrid)

Job Description

General Summary:

The Real World Senior Biostatistician II will perform scientific statistical analyses in support of the company's post-marketing areas for Global Medicines Development and Affairs, and Commercial and Strategic Management, with guidance and mentoring on new and complex issues. The individual will complete assigned work in a resourceful manner and create alternative approaches to achieve desired results. The Senior is expected to develop a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties and Responsibilities:

• Responsible for all scientific and operational statistical work for assigned clinical trials and observational studies, or real world data investigations. Implements design and analysis methods and seeks guidance and mentoring for new and complex issues.
• Participates in regular Study Execution Team meetings. Presents to Statistical Review Forum (SRF) as the functional representative and participates in SRF discussions.
• Provides strategic input and expert technical guidance to team members. Effectively collaborate with multiple stakeholders from Clinical Development, Medical Affairs, Health Economics and Outcome Research, and Real World Evidence teams.
• Under supervision, develops statistical section of protocols, including sample size estimates and randomization plans; authors study Statistical Analysis Plans, including table, figure, and listing (TFL) shells.
• Develops study documents such as Cross-functional Data Review plan, Key Results Memo, and Data Dissemination Plan in order to facilitate the review, summary, and dissemination of key study data/results.
• Provides input into the programming specifications and review. Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
• Contributes to clinical study reports and related processes, authoring or co-authoring methodological or study-related publications and posters.
• Contributes to departmental working group efforts on various advanced technical and operational issues.
• Contributes to external interactions with regulators, payers, review boards, etc.
• Authors or co-authors methodological or study-related publications and posters.

Knowledge and Skills:

• Competence with SAS and R statistical software.
• 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. in Biostatistics or related fields.
• M.S. in Biostatistics or related fields and 3 years of relevant work experience.

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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 Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 
 

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 [email protected]