Job Description
Job Description General Summary:
The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. In addition, the Principal Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer. Key Duties and Responsibilities:
Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools) Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group Demonstrates in-depth knowledge of clinical development and medical data Solves complex clinical trial reporting problems and demonstrates technical proficiency and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and in a timely manner Engages with a variety of other functions, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities, often at Senior Management levels Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP
regulations Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies Knowledge and Skills:
Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
Intermediate knowledge of CDISC Standards Intermediate knowledge of clinical trials Regulatory submission experiences Effective communication (written and verbal) skills to explain difficult information Education and Experience:
Bachelors degree in a Scientific Discipline Typically requires 5+ for M.S. or above and 8+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization Pay Range:
$149,200 - $223,800 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:
Remote-Eligible Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as: 1. Remote:
work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid:
work remotely up to two days per week; or select 3. 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. #LI-Remote 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 Help Us Achieve Our Mission Vertex 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 www.vrtx.com 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.
