Director, Biostatistics

Title: Director, Biostatistics

Location: Brisbane, CA

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

The Director, Biostatistics will report to the VP of Biostatistics and serve as a key member of the cross-functional product development team. The Director contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. They will also play a pivotal role in shaping short- and long-term biostatistics strategies and building infrastructure to support the company’s broader corporate goals.

Responsibilities:

• Contributes to the design of scientifically robust clinical trials, including the selection of study populations, sample sizes, and endpoints to address study objectives.
• Authors and reviews protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), publications, and product-level documents.
• Serves as the primary contact and provides oversight for all biostatistics-related activities outsourced to CROs and other external vendors.
• Reviews clinical data packages (e.g., SDTMs, ADaMs, and reviewer guides) to ensure submission readiness for BLA/NDA filings.
• Collaborates with vendors, Clinical Research, Pharmacovigilance, Regulatory Affairs, Clinical Operations, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
• Presents summary data and analysis results effectively to internal and external stakeholders.
• Provides statistical support and leadership to address health authority requests, publications, presentations, and other public disclosures of information.
• Manages multiple studies within a therapeutic area, ensuring consistency and adherence to established standards.
• Ensures compliance with company processes, SOPs, and regulatory requirements.

Qualifications:

• PhD in Statistics, Biostatistics, or a related scientific field with at least 8+ years of experience in clinical trials within the pharmaceutical or biotechnology industry, or MS with at least 10+ years of relevant experience.
• Proficiency in scientific computing and programming using SAS or R, with expertise in advanced statistical analysis, data manipulation, graphing, and simulation techniques.
• Strong interpersonal, communication, writing, and organizational skills.
• Expertise in statistical and clinical trial methodologies as they pertain to clinical development, with the ability to apply these methodologies effectively.
• Solid understanding of the regulatory landscape and prior experience participating in regulatory interactions.
• Demonstrated collaboration, organizational, and leadership abilities, as well as strong interpersonal skills.
• Proven ability to plan, organize, and prioritize multiple work assignments, with strong project management skills.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $229,000 - $256,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

Notice to Recruiters/Staffing Agencies

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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

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Fraud Alert

To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.

Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.

Last updated on Jan 31, 2025