PTC Therapeutics, Inc. · 22 hours ago
Director, Biostatistics
New Jersey, United States
Full-time
Onsite
Director/Executive
$217K/yr - $260K/yr
8+ years expPTC Therapeutics is a global commercial biopharmaceutical company dedicated to extending life’s moments for those living with rare diseases. The Director, Biostatistics provides technical leadership and operational support for clinical development programs and trials, ensuring adherence to regulatory requirements and delivering high-quality statistical analysis.
BiotechnologyHealth CareTherapeutics
Responsibilities
Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material
Develops solutions to statistical and data analysis issues for clinical and regulatory. Communicates solutions cross-functionally
Participates in vendor evaluation, selection, and management
Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment
Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data in a way that supports a high-quality database for the planned analyses
Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions
Authors and reviews statistical and outcome sections of study reports and submissions
Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities
Performs other tasks and assignments as needed and specified by management
Qualification
Required
A Master's degree in Statistics or a related statistical discipline and a minimum of 8+ years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment
Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies
Demonstrated understanding and working knowledge of advanced statistical theory and its application in the pharmaceutical/biotechnology industry
Hands-on statistical programming skills using SAS and/or R
Ability to influence without direct authority
Proficient in Microsoft Office
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Excellent understanding of regulatory requirements and guidance documents
Preferred
Prior BLA, NDA and/or MAA experience is highly desirable
Benefits
Short- and long-term incentives
Medical, dental, vision, and retirement savings plans
Company
PTC Therapeutics, Inc.
PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.
501-1000 employees
H1B Sponsorship
PTC Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (9)
2023 (14)
2022 (31)
2021 (13)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.57BKey Investors
Brookside CapitalCredit Suisse First Boston
2022-10-27Post Ipo Equity· $1B
2020-05-14Post Ipo Equity· $140.95M
2015-08-14Post Ipo Debt· $150M
Leadership Team
Matthew B. Klein
Chief Executive Officer and President
Stuart Peltz
CEO
Recent News
2026-01-12
2026-01-09
Company data provided by crunchbase