Job Description
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General Summary:
The Biostatistics Associate Director will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent is capable of independent strategic and technical contributions. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
Job Description
General Summary: The Biostatistics Associate Director will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent is capable of independent strategic and technical contributions. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
Key Duties And Responsibilities - 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.
Knowledge And Skills - 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
Education And Experience - Ph.D in Statistics or Biostatistics.
- Typically requires 7 years of experience with a Ph.D. or the equivalent combination of education and experience.
Pay Range $0 - $0
Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status In this Hybrid-Eligible role, you can choose to be designated as:
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs 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 ApplicationAssistance@vrtx.com
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Research, Analyst, and Information Technology
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Job Tags
Full time, Summer work, Remote work, Flexible hours, 2 days per week,