Real director

This job is with Vertex Pharmaceuticals, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Description

The Real World Statistics Director will lead complex project to develop statistical solutions and perform sophisticated scientific statistical functions in support of the company's post-marketing areas for Global Medicines Development and Affairs, and Commercial and Strategic Management. The position will serve Statistics lead role on assigned projects including clinical trials, real world observational studies, market access and reimbursement activities, and other ad hoc analyses, and will make strategic and technical contributions independently for new and complex issues.

The individual will complete assigned work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The individual is expected to understand current and evolving trends and business drivers within the industry and to be able to translate these into meaningful analytical tools to support strategic business decisions. The Director should possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties & Responsibilities

• Is 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 undertakes new and complex issues independently.
• Participates in regular Study Execution Team meetings. Presents to Statistical Review Forum (SRF) as the functional representative and participates in SRF discussions.
• May include management, oversight, and strategic directions of one or more projects or major components of a project.
• May include presentation to the Peer Protocol Review Committee or other internal senior review boards.
• Possesses an advanced and in-depth understanding of modern drug discovery, development, and post-marketing processes.
• Represents Real World Statistics as a member of cross functional teams, providing 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.
• Leads and guides project teams to more meaningful and/or productive ends.
• 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. Leads collaboration 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.

Required Education And Experience

• Ph.D. in Biostatistics or related fields and 10 years of relevant work experience.
• M.S. in Biostatistics or related fields and 13 years of relevant work experience.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• 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 ApplicationAssistance@vrtx.com