Senior Biostatistician II

Job Description
General

Summary:

The Real World Statistics Associate Director will perform sophisticated scientific statistical analyses in support of the company’s post-marketing areas for Global Medicines Development and Affairs, and Commercial and Strategic Management, with minimal guidance and mentoring on new and complex issues. 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.

The individual will complete assigned work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The Associate Director should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

• 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 with minimal guidance.
• 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.
• 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.

• Competence 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.
• Excels in a team environment.
• Collaborates well with non-statisticians.

• Ph.D. in Biostatistics or related fields and 7 years of relevant work experience.
• M.S. in Biostatistics or related fields and 10 years of relevant work experience.

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive…