- Conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations.
- Leads biostatistics projects or major components of a project including work allocation and review.
- May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
- Possesses an advanced and in-depth understanding of modern drug discovery and development processes.
- Represents Biostatistics as a member of cross functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes.
- Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
- Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
- Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters.
- Provides input into programming specifications and review.
- Contributes to external interactions with regulators, payers, review boards, etc.
- Authors or co-authors methodological or study-related publications and posters.
- Determines and implements design and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
- Contributes to departmental working group efforts on various advanced technical and operational issues.
- Independently undertakes new and complex issues.
- Completes assigned work in a resourceful, self-sufficient manner, often conceptualizing alternative approaches to achieve desired results.
- Develops breadth of knowledge across related disciplines with a drug developer mindset.
- In-depth competence with SAS and R statistical software
- In-depth 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
- NDA/MAA experience and direct dealings with USA/European regulators
- Ph.D. in Statistics or Biostatistics.
- Typically requires 7 years of experience with a Ph.D.
Associate Director, Biostatistics - Boston, MA, United States - Vertex Pharmaceuticals
Description
Associate Director, Biostatistics page is loaded
Associate Director, Biostatistics
Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-20839Job Description
General Summary:
As a Biostatistics Associate Director at Vertex, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may lead to medical breakthroughs.
You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatments and improving global well-being.
The Associate Director will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area on new and complex issues. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
This position is hybrid, with a work schedule that allows for 2 days per week remote-based work and 3 days per week in the Fan Pier office
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
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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
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locations Boston, MA time type Full time posted on Posted 30+ Days AgoVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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