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About the Role
The Real World Statistics Associate Director will perform sophisticated scientific statistical analyses for post-marketing areas, clinical trials, real world observational studies, and market access activities. This role requires minimal guidance on complex issues and involves serving as the Statistics lead on assigned projects, demonstrating a drug developer mindset and knowledge of related disciplines.
Responsibilities
- Responsible for all scientific and operational statistical work for assigned clinical trials, observational studies, or real world data investigations.
- Implements design and analysis methods and addresses new and complex issues with minimal guidance.
- Participates in regular Study Execution Team meetings.
- Presents to the 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.
- Represents Real World Statistics as a member of cross-functional teams, providing strategic input and expert technical guidance.
- Effectively collaborates 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.
- 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.
- Authors or co-authors 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.
Requirements
- Possesses an advanced and in-depth understanding of modern drug discovery, development, and post-marketing processes.
- Ability to show critical thinking with logical problem-solving.
- 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.
- Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
- Seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Skills
- Competence with SAS and R statistical software.
- Demonstrated understanding of advanced statistical methods used in drug development.
- Excellent written and verbal communication skills.
Location
- Hybrid-Eligible
- On-Site Eligible
Work Type
- Hybrid
- On-Site
Experience Level
- 7 years of relevant work experience (with Ph.D.)
- 10 years of relevant work experience (with M.S.)
Education Level
- Ph.D. in Biostatistics or related fields
- M.S. in Biostatistics or related fields
About the Company
- Vertex is a global biotechnology company that invests in scientific innovation.
Equal Opportunity
- 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