Internal Application: Associate Director, Statistical Programming

Title: Associate Director, Statistical Programming

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:

Reporting into the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for supporting Clinical Development programs by performing Statistical Programming tasks as well as building and computing the analytical programming environment.

Responsibilities:

• Oversee and work directly with CROs to provide guidance, and effectively monitor their deliveries for quality, time and budget adherence
• Follow CDISC, SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and key TFLs generated by the CRO
• Work with the internal team and CRO to prepare submission-readiness datasets (e.g. SDTMs, ADaMs) and metadata to support the BLA filing
• Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, RTQ, and ad hoc analyses
• Attend SMT, and collaborate with the study statistician and other study team members in project planning and timeline discussions
• Review key study documents including but not limited to study protocol, SAP, and CDM documents and provide inputs to represent statistical programming function
• Work collaboratively with stakeholders and other developmental functions to standardize, maintain, and implement the data transformation and statistical analysis requirements
• Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit
• Support Biometrics and collaborate with IT, QA, and external vendor(s) to build and maintain a secure statistical computing environment and programming infrastructure
• Support the development and implementation of programming SOPs, work instructions, including programming production, validation, and server working instruction documentation

Qualifications:

• Bachelor's degree in Statistics, Life Sciences, Computer Science, or related fields. (Master’s preferred)
• 8+ years of statistical programming experience in the pharmaceutical industry (experience with immunological diseases a plus)
• Experience with BLA or NDA/sNDA, FDA (EMA experience a plus)
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat (experience with R and JMP a plus)
• Extensive experience managing CROs for clinical and statistical programming activities
• Broad knowledge of medical/biological terminology in relevant therapeutic areas, good knowledge of drug development regulations for statistical analysis
• Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
• Excellent communication skills, with the ability to effectively develop and deliver strategically, while aligning and gaining the collaboration of cross-functional groups
• Able to effectively lead functional and cross-functional projects of varying scope and complexity while prioritizing resources
• Strong hands-on programming skills to deliver results in a fast-moving environment

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 $189,000 - $213,000. 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.

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