- Associate Director, Biostatistics Puerto Diablo
- Buscojobs PR C2 in Puerto Diablo, Vieques, Puerto Rico
- jobs
- 2 months ago
jobs description
Job SummaryThe Associate Director, Real-World Statistics will oversee and perform complex scientific statistical analyses in support of the company's post-marketing areas for Global Medicines Development and Affairs (GMDA) and Commercial and Strategic Management (CSM), on new and complex issues with minimal guidance and mentoring.Key Responsibilities• Responsible for all scientific and operat...ional statistical work for multiple clinical trials and observational studies, or real-world data (RWD) investigations.• May include management, oversight, and strategic directions of one or more projects or major components of a project.• Mentors junior personnel, possibly including one or more direct reports.• 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, 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 collaborates with multiple stakeholders from Clinical Development, Medical Affairs, Health Economics and Outcome Research (HEOR), and Real-World Evidence (RWE) teams.• Develops technical leadership and guides project teams to more meaningful and/or productive ends.• Authors study Statistical Analysis Plans (SAPs), 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.• 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.• Contributes to external interactions with regulators, payers, review boards, etc.• Authors or co-authors methodological or study-related publications and posters.• Contributes to departmental working group efforts on various advanced technical and operational issues.RequirementsPh.D. in Biostatistics or related fields and 7 years of relevant work experience, or M.S. in Biostatistics and 10 years of relevant work experience.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, and collaborates well with non-statisticians.About UsVertex 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 **phone number**.#**job id**
Puerto Diablo Vieques Puerto Rico