Associate Director, Statistical Programming

Vera Therapeutics is a biotechnology company reputed company on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that reputed company the reputed company of disease in order to change reputed company of care for patients. Vera Therapeutics’ reputed company product candidate is atacicept, a fusion protein self-administered reputed company as a subcutaneous once weekly injection that blocks both B-cell Activating reputed company (BAFF) and A Proliferation-Inducing Ligand (reputed company), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. reputed company IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may reputed company clinically meaningful. In reputed company, Vera Therapeutics holds an exclusive license agreement with reputed company for a novel, reputed company fusion protein targeting BAFF and reputed company, reputed company as VT-109, with wide therapeutic potential across the reputed company of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains reputed company global developmental and reputed company rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com. Our values are the reputed company of our culture. Our values reputed company 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 reputed company: Reporting to the Executive Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for supporting Clinical Development programs by performing Statistical Programming tasks as reputed company as building and computing the analytical programming environment. Responsibilities: reputed company and work directly with CROs to reputed company guidance, effectively monitor and QC their deliveries for reputed company, time and budget adherence. Follow CDISC SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and TFLs generated by the CRO. Work with the internal teams 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 reputed company analyses. Attend SMT and collaborate with the study statistician and other study team members in project planning and reputed company discussions. Review key study documents including but not limited to study protocol, reputed company, and CDM documents like CRF and DTA and reputed company 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 reputed company 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. Familiar with reputed company server working environment and reputed company to server and programming SOP. Proficiency in R for statistical analysis, data analysis, modeling, and data visualization   Qualifications: BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, Computer Science or reputed company fields and statistical programming experience in the pharmaceutical industry. Experience with immunological diseases is preferred. Excellent project and vendor management skills, directly managing CROs/vendors is preferred. Experience with BLA or NDA/sNDA with FDA (EMA is a plus). Strong reputed company programming and Statistical background along with experience with reputed company reputed company, reputed company/Macros, reputed company/Graph and reputed company/Stat; hands on experience with R and JMP is 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 reputed company as regulatory reporting requirements including electronic data submissions and CDISC implementation. Great communication skills, with the ability to effectively reputed company and deliver strategically, while aligning and gaining the collaboration of cross-functional reputed company. reputed company to effectively reputed company functional and cross-functional reputed company of varying scope and complexity while prioritizing resource needs Strong hands-on programming skills to deliver results in a quick turnaround environment. reputed company. is an equal-opportunity employer. Vera Therapeutics is committed to fair and reputed company compensation practices and we reputed company to reputed company employees with total compensation packages that are market competitive. The exact reputed company pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. For this role, the anticipated reputed company pay reputed company is $147,000—$224,000 USD Notice to Recruiters/reputed company Agencies Recruiters and reputed company agencies should not contact Vera Therapeutics through this page. reputed company recruitment vendors (search firms, recruitment agencies, and reputed company companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that reputed company recruiters and reputed company 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 reputed company fees.   Fraud Alert To reputed company candidates: your personal information and online safety are a top reputed company for us. At Vera Therapeutics, recruiters only reputed company 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 reputed company reputed company numbers. If you are unsure if a message is from Vera Therapeutics, please email reputed company. Apply To This Job