We are a clinical-stage biotechnology company developing treatments that transform patients’ lives.
Associate Director, Statistical Programming
Location
United States
Posted
37 days ago
Salary
$147K - $224K / year
Seniority
Senior
Job Description
Associate Director, Statistical Programming
Vera Therapeutics, Inc.
• Oversee and work directly with CROs to provide guidance, effectively monitor and QC their deliveries for quality, 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 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 like CRF and DTA 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. • Familiar with SAS server working environment and adherent to server and programming SOP. • Proficiency in R for statistical analysis, data analysis, modeling, and data visualization
Job Requirements
- BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, Computer Science or related 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 SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/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 well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
- Great 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 resource needs.
- Strong hands-on programming skills to deliver results in a quick turnaround environment.
Benefits
- Vera Therapeutics Inc. is an equal-opportunity employer.
- Vera Therapeutics is committed to fair and equitable compensation practices.
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