Associate Director, Biostatistics

Title : Associate Director, BiostatisticsLocation : Brisbane, CaliforniaAbout 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 fully humanized fusion protein self-administered as a subcutaneous injection once weekly that blocks both B -cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce galactose deficient IgA1 (Gd-IgA1) and associated auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN).

In addition, Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is 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 Associate 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 biostatistics infrastructure development to support long-term department 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 project biostatistician 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 provide scientifically rigorous statistical expertise 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 (5+ years) or MS (8+ 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 $197,000 - $215,000. 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.

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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.

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