Full-Time
Head of Biostatistics
Posted on 2/22/2025
Verve Therapeutics
201-500 employees
Develops gene editing therapies for cardiovascular disease
Senior, Expert
Boston, MA, USA
You match the following Verve Therapeutics's candidate preferences
Employers are more likely to interview you if you match these preferences:
- Advanced degree in biostatistics, statistics, mathematics, or a related field.
- A minimum of 12 years of experience in biostatistics for clinical development, including extensive experience with Phase 3 clinical trials and New Drug Application (NDA) and/or Biological License Application (BLA) submissions.
- Strong expertise in statistical methods for diagnostic and clinical development, including mixed effects regression and time-to-event models, along with proficiency in SAS, R, and clinical data management systems.
- Proven experience leading biostatistics and data sciences in the biotechnology industry, aligning data strategies with program goals and driving innovation.
- Expertise in shaping and executing statistical strategies for clinical trials, ensuring data integrity, regulatory compliance, and scientific rigor.
- Experience preparing regulatory submission documents (statistical analysis plans, clinical study reports) and ensuring compliance with industry standards.
- Expertise in designing clinical trials and refining data collection processes with optimal statistical methodologies.
- Fluent in CDISC data standards, including SDTM and ADaM.
- Knowledge of FDA, EMA, and ICH regulations and guidelines related to clinical trials, biostatistics and data handling.
- Experience in outsourced vendor management and external partnership governance.
- Experience developing departmental standards and process improvement initiatives.
- Proven ability to lead and develop high-performing teams, align talent strategies with the company's vision, foster innovation, and inspire teams while developing future leaders.
- Demonstrated ability to develop and implement growth-oriented strategies and initiatives.
- Advanced strategic thinking skills with a track record of anticipating and responding to industry trends.
- Excellent interpersonal and communication skills, with the ability to navigate complex organizational dynamics.
- Experience in talent development and aligning employee career goals with organizational objectives.
- Develop and implement biostatistical strategies for clinical trials and research studies, ensuring they align with regulatory requirements and organizational objectives.
- Provide statistical leadership for the design and analysis of clinical trials, focusing on cardiovascular editing gene therapies.
- Serve as the biostatistics expert for clinical trial programs, from preclinical through late-stage development and regulatory submission.
- Oversee the design, analysis, and interpretation of clinical trial data, ensuring the use of advanced statistical methodologies, including survival analysis, Bayesian methods, and longitudinal data analysis.
- Conduct power and sample size calculations, ensuring the statistical rigor of study designs.
- Review and validate clinical trial data for consistency and clarity, ensuring accuracy throughout the trial lifecycle.
- Provide clear, actionable insights through statistical reports, presentations, and graphical data representations for clinical teams, senior leadership, and regulatory agencies.
- Assist in developing study protocols by incorporating statistical methodologies that support clinical objectives, participate in preparing and submitting regulatory filings to ensure statistical sections meet regulatory standards (e.g., FDA, EMA).
- Provide statistical consulting to researchers and clinical staff to optimize trial design and analysis in alignment with business and regulatory goals.
- Stay abreast of advancements in clinical research methodologies and biostatistics, adapting strategies to meet evolving industry trends and regulatory requirements.
- Ensure the highest standards of data accuracy, integrity, and consistency in all clinical trial data analysis.
- Oversee the review and audit of clinical trial data, ensuring compliance with industry best practices and regulatory requirements.
- Work closely with cross-functional teams, from clinical research, clinical operations, data management, and regulatory affairs to design and execute innovative clinical studies that drive progress and provide valuable insights.
- Forge strong partnerships with external collaborators, including CROs, academic institutions, and industry leaders, to accelerate program development and amplify the company’s impact.
- Develop lasting relationships with both internal and external stakeholders, fostering alignment and creating a collaborative environment that supports mutual success and growth.
- Make key decisions that influence the organization’s long-term performance and strategic objectives.
- Lead the growth and development of a high-performing biostatistics team by aligning talent strategies with the company’s vision, fostering a culture of collaboration, creativity, and excellence.
- Inspire and empower team members to thrive in a dynamic, fast-paced environment, while mentoring them to take on leadership roles and drive high performance, accountability, and innovation.
- Champion innovation by empowering teams to think creatively, embrace diverse perspectives, and implement best practices.
- Demonstrate strong interpersonal skills, effectively managing conflicts, fostering respectful interactions, and promoting a collaborative, inclusive workplace culture.
Verve Therapeutics focuses on developing gene editing therapies to treat cardiovascular disease. The company uses gene editing technologies to create single-course treatments that aim to provide lasting solutions for patients, rather than relying on ongoing management therapies. Their initial efforts are directed at modifying the PCSK9 and ANGPTL3 genes, which are known to help lower blood lipid levels. This approach is different from many competitors who often offer chronic management options. Verve's goal is to provide potentially curative treatments for individuals with cardiovascular conditions, generating revenue through the commercialization of their therapies and partnerships with other healthcare entities.
Company Size
201-500
Company Stage
IPO
Total Funding
$353.6M
Headquarters
Cambridge, Massachusetts
Founded
2018
Simplify's Take
What believers are saying
- Eli Lilly's $60M investment shows confidence in Verve's cardiovascular gene editing approach.
- CRISPR therapy approvals, like Casgevy, pave the way for Verve's regulatory success.
- CRISPR's success in genetic blindness supports Verve's potential in cardiovascular treatments.
What critics are saying
- Rapid CRISPR advancements may increase competition, affecting Verve's market share.
- Most CRISPR therapies are in early stages, delaying Verve's market entry and revenue.
- Verve's stock drop post-offering suggests investor concerns about financial stability.
What makes Verve Therapeutics unique
- Verve focuses on single-course gene editing for cardiovascular diseases, unlike chronic treatments.
- The company targets PCSK9 and ANGPTL3 genes, crucial for lowering blood lipid levels.
- Verve's approach offers potentially curative treatments, setting it apart in the biotech sector.
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Benefits
Hybrid Work Options
Growth & Insights and Company News
6 month growth
↑ 1%1 year growth
↑ 1%2 year growth
↑ 3%The CRISPR RevolutionCRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a recently discovered tool for genetic editing. It allows for very precise and directed gene editing, and its discoverers have won the 2020 Nobel Prize.The initial CRISPR system discovered was CRISPR-Cas9, and many modified CRISPR systems have been discovered or created since. You can read more about the technical details of CRISPR in our article “What Is CRISPR-Cas12a2? Why Does It Matter?”CRISPR is at the forefront of the genomic revolution, with the first gene therapies using it now getting approved for blood diseases, something we explored in depth in “How CRISPR Companies Target Sickle Cell Anemia”.Almost every month that passes seems to bring a brand new revolutionary CRISPR therapy or application. The latest in date is curing a rare form of blindness.Curing Blindness With CRISPR?In a scientific paper titled “Gene Editing for CEP290-Associated Retinal Degeneration”, researchers and doctors at the Universities of Harvard Medical School, Pennsylvania, Michigan, Miami, Oregon Health and Science, as well as Perelman School of Medicine and Editas Medicine have seen remarkable results in treating a disease called Leber Congenital Amaurosis (LCA)LCA causes the degradation of the vision in the first early months of life. There is currently no treatment for LCA, and affects an estimated 50,000 people in the USA and 180,000 people worldwide.After a break in 2022, Editas Medicine announced in May 2024 that the clinical trial for EDIT-101 has seen 79% of the 14 clinical trial participants experience measurable improvement after receiving the experimental gene therapy.“One of our trial participants has shared several examples, including being able to find their phone after misplacing it and knowing that their coffee machine is working by seeing its small lights.While these types of tasks might seem trivial to those who are normally sighted, such improvements can have a huge impact on quality of life for those with low vision.” – Mark Pennesi, M.D., Ph.D. – Oregon Health Science University’s lead scientistNext Steps For EDIT-101Now that the efficiency of the treatment is proven, and there were no serious side effects, the next step is determining the “ ideal dosing, whether a treatment effect is more pronounced in certain age groups such as younger patients, and include refined endpoints to measure impacts on activities of daily living.”“Our hope is that the study will pave the road for treatments of younger children with similar conditions and further improvements in vision.This trial represents a landmark in the treatment of genetic disease, in specific genetic blindness, by offering important alternative treatment when traditional forms of therapy, such as gene augmentation, are not an option.” – Tomas S. Aleman, M.D
Pictured: Illustration of a gloved hand holding tweezers and editing DNA/iStock, LadadikArtThe era of CRISPR gene-editing technology has arrived. With the approval of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exa-cel) in two indications, the question now is, what’s next?In short, the answer to that question is not much right now. While the cell and gene therapy sector as a whole is expecting continued growth in terms of approvals, CRISPR-based therapies are predominately early stage.CRISPR Pipeline Skews Toward DiscoveryThe December and January approvals of Casgevy for sickle cell disease and transfusion-dependent beta thalassemia represent a landmark for gene therapy. Casgevy is the first approved treatment that uses CRISPR/Cas9 gene-editing technology. The one-time treatment can be curative for these serious, life-altering blood disorders.But Casgevy will not open any immediate floodgates to CRISPR therapy approvals, as most potential CRISPR-based treatments are still in the earlier stages of development. According to a December 2023 report from GlobalData, discovery and preclinical assets account for 88% of the CRISPR drug candidates currently under investigation, with 24 CRISPR-based therapeutics in Phase II trials and one other than Casgevy in Phase III.Thus, despite the milestone approval of Casgevy, GlobalData analyst Jasper Morley believes the industry is “unlikely to see another [CRISPR] drug approval in the near future.”While hematological drugs are the most advanced, out of 262 active drugs in the discovery and preclinical stage, oncology dominates—accounting for some 25%—Morley told BioSpace in an email
By Colin Kellaher Verve Therapeutics shares fell more than 10% in premarket trading Wednesday after the clinical-stage biotechnology said it was raising about $148 million in a public offering...
Eli Lilly has secured the rights to Verve Therapeutics’ gene editing approach, a “one-and-done” method that the companies hope will lower the cardiovascular risk factor lipoprotein(a).
Verve Therapeutics announced today that it has raised $63 million in a Series A2 financing from both existing and new investors.