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Real World Statistics Associate Director

  • Job
    Full-time
    Senior & Expert Level
  • Munich
  • Quick Apply

AI generated summary

  • You must have expertise in real-world data analysis, strong statistical skills, and experience in pharmaceuticals or related fields to drive insights for strategic decision-making.
  • You will analyze real-world data, collaborate with cross-functional teams, lead projects, and provide statistical insights to support decision-making in drug development and commercialization.

Requirements

  • - 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./M.S. in Biostatistics or extensive years of relevant work experience.

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 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.

FAQs

What is the primary responsibility of the Real World Statistics Associate Director?

The primary responsibility is to 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, serving as the Statistics lead on assigned projects, which include clinical trials, real world observational studies, market access and reimbursement activities, and other ad hoc analyses.

What kind of statistical analyses will the Associate Director be responsible for?

The Associate Director will be responsible for all scientific and operational statistical work related to assigned clinical trials and observational studies or real-world data investigations, including implementing design and analysis methods for complex issues with minimal guidance.

What qualifications are required for this position?

A Ph.D. or M.S. in Biostatistics or extensive relevant work experience is required for this position.

Which statistical software should the Associate Director be proficient in?

The Associate Director should be competent in SAS and R statistical software.

How does the position facilitate collaboration with other departments?

The Associate Director will effectively collaborate with multiple stakeholders from areas such as Clinical Development, Medical Affairs, Health Economics and Outcome Research, and Real World Evidence teams, providing strategic input and expert technical guidance.

Will the Associate Director have the opportunity to present research findings?

Yes, the Associate Director may be responsible for presenting to the Peer Protocol Review Committee or other internal senior review boards, as well as participating in regular Study Execution Team meetings and presenting to the Statistical Review Forum.

Is this position hybrid-eligible?

Yes, this position is hybrid-eligible. The individual can choose to work remotely up to two days per week or work five days per week on-site with some ad hoc flexibility.

What types of outputs is the Associate Director expected to contribute to?

The Associate Director is expected to develop statistical sections of protocols, author Statistical Analysis Plans (including table, figure, and listing shells), contribute to clinical study reports, and author or co-author methodological or study-related publications and posters.

What skills are emphasized for successful performance in this position?

Key skills include competence with advanced statistical methods used in drug development, critical thinking, logical problem-solving, excellent written and verbal communication skills, teamwork, and the ability to collaborate effectively with non-statisticians.

What commitment does Vertex have in terms of employment opportunities?

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants, regardless of race, color, sex, gender identity or expression, age, religion, national origin, disability, or any characteristic protected under applicable law.

The Science of Possibility

Science & Healthcare
Industry
1001-5000
Employees
1989
Founded Year

Mission & Purpose

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.