Senior Biostatistician II (Hybrid)

Posted 18 Hours Ago
Be an Early Applicant
Boston, MA
Entry level
Biotech • Pharmaceutical
The Role
The Senior Biostatistician II conducts statistical functions for clinical trials and observational studies, creates Statistical Analysis Plans, collaborates on data reviews, and contributes to clinical study reports. This role involves innovative designs and analysis, requiring strong communication and teamwork skills.
Summary Generated by Built In

Job Description

The Senior Biostatistician II will perform scientific statistical functions in support of the company’s Global Medicines Development and Affairs (GMDA) area with guidance and mentoring on new and complex issues. In this role you will create alternative approaches to achieve desired results if needed and will develop a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

 

Key Responsibilities:

 

The Senior Biostatistician II works under the supervision of the Biostatistics project or program lead. The Senior Biostatistician:

·       Is responsible for the design, development and execution of the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational studies, or real world data (RWD) investigations, including related areas/activities.

·       Participates in regular Study Execution Team (SET) team meetings as the functional representative.

·       Works under supervision to author study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells, and presentation to Statistical Review Forum (SRF).

·       Plans and conducts Cross-functional Data Review (xFDR) , Key Results 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 good quality. Provides input into programming specifications and review.

·       Develops statistical section of protocols, including sample size estimates and randomization plan.

·       Contributes to clinical study reports (CSRs) and related processes.  Also authors or co-authors methodological or study-related publications and posters.

·       Implements innovative designs and analysis methods at the study level and participates in SRF discussions of studies assigned to others.

·       Contributes to departmental working group efforts on various technical and operational issues.  

 

Minimum Qualifications

 

·       Ph.D. in Statistics or Biostatistics and 0-3 years relevant experience.

·       Competence with SAS and R statistical software

·       Demonstrated understanding of 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

#LI-AR1

# LI-Hybrid

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 [email protected]

Top Skills

R
SAS
The Company
HQ: Boston, MA
5,000 Employees
Hybrid Workplace
Year Founded: 1989

What We Do

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.

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