Real World Principal Biostatistician

Vertex Inc.; München; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

Vertex Inc. is seeking a Real World Principal Biostatistician to perform advanced statistical analyses for post-marketing and real-world evidence initiatives.

The role may lead statistics on trials, observational studies, market access analyses, and other ad hoc projects with thoughtful, drug-development minded approaches. The candidate will draft statistical analysis plans, TFLs, and key study documents, collaborate with multiple stakeholders, and contribute to regulatory and dissemination

Qualifications

• Ph.D. in Biostatistics or related field with 3 years of relevant work experience, or an M.S. with 6 years of experience.
• Experience applying advanced statistical methods in drug development or real-world evidence.
• Ability to lead statistical sections of protocols and TFLs with minimal supervision.

Responsibilities

• Lead scientific and operational statistical work for clinical trials and observational studies.
• Present analyses and participate in SRF discussions as the functional statistician.
• Provide strategic input and guidance to cross-functional teams (Clinical Development, Medical Affairs, HEOR, RWE).
• Possibly manage one or more projects or major components.
• Develop statistical sections of protocols, sample size estimates, and randomization plans.

Skills

Statistical reasoning

Team collaboration

Problem solving

Scientific communication

Education

Ph.D. in Biostatistics or related field

M.S. in Biostatistics

Tools

SAS

R

Job description

Job Description

General Summary

The Real World Principal Biostatistician will perform advanced scientific statistical analyses in support of the company’s post-marketing areas for Global Medicines Development and Affairs, and Commercial and Strategic Management, with some guidance and mentoring on new and complex issues. The position may 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 principal should possess 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 undertakes new and complex issues with some guidance.
• 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.
• May include management, oversight, and strategic directions of one or more projects or major components of a project.
• Possesses an advanced and in-depth understanding of modern drug discovery, development, and post-marketing processes.
• With minimal 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.
• 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.

Education and Experience

• Ph.D. in Biostatistics or related fields and 3 years of relevant work experience, or
• M.S. in Biostatistics and 6 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 innovation, increase efficiency, and help deliver better outcomes for patients.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

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 [e-mail]