Principal Biostatistician

Reposted Yesterday
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Boston, MA, USA
In-Office
175K-262K Annually
Senior level
Biotech • Pharmaceutical
The Role
The Associate Director leads biostatistics efforts in clinical trials, manages team members, authors statistical plans, and collaborates cross-functionally while ensuring quality and compliance with regulatory standards.
Summary Generated by Built In

Job Description

General Summary:

The Principal Biostatistician will perform advanced scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with some 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 should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties and Responsibilities:

Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including the design, development and execution of the technical/statistical infrastructure.

Possesses an advanced understanding of modern drug discovery and development processes.

Represents Biostatistics as a member of clinical trial teams, providing input and technical guidance to elicit meaningful and/or productive outcomes.

With minimal guidance, 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) 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.

Contributes to external interactions with regulators, payers, review boards, etc.

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

Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review.

Implements design and analysis methods at the study 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.

Undertakes new and complex issues with minimal guidance

Completes assigned work in a resourceful, self-sufficient manner and creates alternative approaches to achieve desired results if needed.

Develops breadth of knowledge across related disciplines with a drug developer mindset.

Knowledge and Skills:

In-depth experience 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

Collaborates well with non-statisticians

Education and Experience:

Typically requires 3 years of experience with a Ph.D. or 6 years of experience with a master's degree, or the equivalent combination of education and experience.

•Ph. D. or master's degree in Statistics or Biostatistics.

Pay Range:

$174,800 - $262,200

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: 
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. 

#LI-Hybrid
 

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]

Skills Required

  • Ph.D. or master's degree in Statistics or Biostatistics
  • 7 years of experience with a Ph.D. or 10 years with a master's degree
  • In-depth competence with SAS and R statistical software
  • Some prior staff management experience
  • NDA/MAA experience and direct dealings with USA/European regulators

Vertex Pharmaceuticals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.

  • Parental & Family Support Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
  • Leave & Time Off Breadth Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
  • Retirement Support Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.

Vertex Pharmaceuticals Insights

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The Company
HQ: Boston, MA
5,000 Employees
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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