Director, Biostatistics

Title: Director, Biostatistics

Location: Brisbane, CA

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late-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 fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing 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 is a member of a cross-functional product development team and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Reporting to the Vice President, Biostatistics this position will also contribute to short- and long-term biostatistics strategies and infrastructure development to support broad corporate goals.

Responsibilities:

• Contributes to the design of scientifically sound clinical trials, including the selection of study population/sample size/endpoints to address study objectives
• Authors/reviews protocol, statistical analysis plan, clinical study reports, publications, and product level documents
• Acts as the primary contact and able to act as the lead functional representative for all biostatistics related activities outsourced to CROs and other external vendors
• Works collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting
• Presents summary data and analyses results in an effective manner
• Provides statistical support and serves as leader in addressing health authority requests, publications, presentations, and other public release of information
• Manages multiple studies to ensure consistency and adherence to standards within a therapeutic area
• Responsible for complying with all company processes and SOPs

Qualifications:

• PhD (8+ years) or MS (10+ years) in statistics or biostatistics or related scientific field with experience in clinical trials in the pharmaceutical or biotechnology industry
• Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation
• Excellent communication skills with the ability to deliver difficult or complex messages and provide feedback with both tact and diplomacy
• Expertise in statistical/clinical trials methodology as it relates to clinical development and ability to apply to relevant clinical development framework that will significantly advance the teams’ capabilities and performance
• Good understanding of regulatory landscape and experience with participating in regulatory interactions
• Able to identify opportunities for strategic cross-functional collaborations that can carry significant impact to the business
• Proven project management skills with the ability to plan, organize, and prioritize multiple work assignments

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 $241,000 - $271,000. 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.

COVID-19 Policy

Vera’s top priority is the health and safety of our employees, their families and the communities where they live and work. As part of our commitment to health and safety, we require all U.S. employees to be fully vaccinated against COVID-19. If your role at Vera requires you to work or otherwise be on Vera’s premises, full or part-time, we require our employees to comply with Vera’s mandatory COVID-19 vaccination policy (currently requiring full vaccination). Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, may request a reasonable accommodation with Human Resources. Your employment is also subject to ongoing compliance with the mandatory vaccination policy and all other Vera policies, as they may be modified from time to time, at the sole discretion of Vera.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

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

Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.