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 in order 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:
Our values are the cornerstone of our culture, guiding everything we do—from hiring great people to advancing our mission together.
Position Summary:
Reporting into 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-readiness datasets (e.g., SDTMs, ADaMs) and metadata to support the BLA filing.
- Perform hands-on statistical programming to support CSR, publications, presentations, safety data review, and ad hoc analyses.
- Attend SMT and collaborate with the study statistician and other team members in project planning.
- Review key study documents and provide inputs to represent the statistical programming function.
- Standardize, maintain, and implement data transformation and statistical analysis requirements.
- Ensure programming and data compliance with GCP, SOPs, and regulatory requirements.
- Familiarity with SAS server working environment and adherence to server and programming SOP.
Qualifications:
- BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, Computer Science, or related fields with 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, FDA (EMA is preferred) is a plus.
- Strong SAS programming and statistical background, experience with R and JMP is a plus.
- Extensive experience managing CROs for clinical and statistical programming activities.
- Broad knowledge of medical/biological terminology and drug development regulations for statistical analysis.
- Thorough understanding of clinical trial design and reporting processes, and regulatory reporting requirements.
- Strong communication skills, with the ability to collaborate with cross-functional groups.
- Able to lead functional and cross-functional projects while prioritizing resource needs.
- Strong hands-on programming skills to deliver results quickly.
Equal Opportunity Employer:
Vera Therapeutics Inc. is an equal opportunity employer. We are committed to fair compensation practices and strive to provide market competitive total compensation packages.
The anticipated base pay range for this role is $169,000 - $194,000, depending on factors such as geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity, along with various benefits offerings.
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