Senior Director Biometrics at Vor Bio

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Advanced degree (PhD or MS) in Biostatistics, Statistics, Mathematics, or a related field
Extensive experience (10+ years) in biometrics leadership roles within the pharmaceutical, biotechnology, or CRO industry
Proven track record in designing and analyzing clinical trials (Phase I-IV), including regulatory submissions (NDA/BLA/MAA)
Expert knowledge of statistical software (e.g., SAS, R) and clinical data management systems
Strong understanding of global regulatory requirements (FDA, EMA, ICH guidelines)
Exceptional leadership, communication, and organizational skills
Ability to work collaboratively in a fast-paced, matrixed environment
Strategic Thinking: Ability to set vision and direction for biometrics functions
Technical Expertise: Deep understanding of statistical methodologies and clinical data standards
Collaboration: Skilled at building relationships across disciplines and driving cross-functional initiatives
Problem Solving: Proactive in identifying challenges and implementing effective solutions
People Development: Committed to mentoring and growing staff

Responsibilities

Lead and manage the biometrics function, including biostatistics, data management, and statistical programming teams
Develop and implement biometrics strategies to support clinical development plans, regulatory submissions, and post-marketing activities
Oversee design, analysis, and interpretation of clinical trials, ensuring statistical rigor and compliance with regulatory standards
Establish and maintain best practices for data collection, management, and analysis, ensuring data integrity and quality
Collaborate with cross-functional teams (clinical, regulatory, medical, and project management) to align biometrics deliverables with program objectives
Provide expert guidance on statistical methodologies, protocol development, and study design
Represent biometrics in interactions with regulatory agencies, external partners, and key stakeholders
Mentor and develop biometrics staff, fostering a culture of excellence, innovation, and continuous improvement
Monitor industry trends and emerging technologies to enhance biometrics capabilities and processes

Skills

Biostatistics

Data Management

Statistical Programming

Clinical Development

Regulatory Submissions

Clinical Trials

Vor Bio

Develops targeted therapies for blood cancers

About Vor Bio

Vor Biopharma focuses on developing treatments for blood cancers, particularly Acute Myeloid Leukemia (AML). Their approach is designed to protect healthy cells while specifically targeting and eliminating cancerous cells. This method aims to improve the effectiveness of blood cancer treatments. Vor Biopharma serves patients with blood cancers, their caregivers, and medical professionals in hospitals and oncology centers. What sets Vor Biopharma apart from competitors is their strong emphasis on research and development, investing significantly in scientific research to create a proprietary platform and pipeline of therapies. They generate revenue through partnerships with other pharmaceutical companies and licensing agreements, with the goal of commercializing their therapies after obtaining regulatory approval. The company's mission is to transform the treatment landscape for blood cancers by providing innovative therapies that prioritize patient safety and efficacy.

Cambridge, MassachusettsHeadquarters

2015Year Founded

$147.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Vacation

Parental Leave

401(k) Retirement Plan

401(k) Company Match

Commuter Benefits

Risks

Significant YTD price decline of -62.76% may affect investor confidence.

Key clinical trial data updates are not expected until 2025, causing uncertainty.

Increased competition from companies like Editas Medicine poses potential conflicts.

Differentiation

Vor Bio focuses on protecting healthy cells while targeting cancerous ones.

The company specializes in innovative treatments for blood cancers like AML.

Vor Bio's approach aligns with the rise of personalized medicine.

Upsides

Recent $55.6M funding supports clinical trials and extends cash runway to 2025.

FDA's acceptance of gene therapies may ease approval for Vor Bio's treatments.

Advancements in CRISPR technology enhance precision of Vor Bio's gene editing.

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