Title: Associate Director, Statistical Programming Location: Brisbane 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 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 injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL). Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus. For more information, please visit: .
Position Summary: Reporting to the Senior Director, Statistical Programming, the Associate Director will be responsible for supporting Clinical Development programs by performing Statistical Programming tasks and building the analytical programming environment.
Responsibilities: Oversee and work directly with CROs to provide guidance, monitor, and QC their deliveries for quality, time, and budget adherence. Follow CDISC SDTM and ADaM standards; validate SDTM, ADaM datasets and TFLs generated by the CRO. Prepare submission-ready datasets (e.g., SDTMs, ADaMs) and metadata to support the BLA filing. Perform hands-on statistical programming to support CSR, publications, presentations, and safety data review. Collaborate with the study statistician and other team members in project planning and timeline discussions. Review key study documents and provide inputs to represent the statistical programming function. Work collaboratively with stakeholders to standardize and implement data transformation and statistical analysis requirements. Ensure compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF). Familiarity with SAS server working environment and adherence to programming SOP. Qualifications: BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, or related fields with statistical programming experience in the pharmaceutical industry. Experience with immunological diseases is preferred. Excellent project and vendor management skills. Experience with BLA or NDA/sNDA, FDA (EMA is preferred) is a plus. Strong SAS programming skills with experience in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat; 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. Thorough understanding of clinical trial design and reporting processes, as well as regulatory reporting requirements. Strong communication skills, able to lead projects and align cross-functional groups. Strong hands-on programming skills to deliver results in a quick turnaround environment. Vera Therapeutics Inc. is an equal opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices. The anticipated base pay range for this role is $169,000 - $194,000, depending on various factors.
At Vera, base pay is part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus and various benefits including medical, dental, and vision insurance, 401k match, and flexible time off.
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