Description:
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 well as building and computing the analytical programming environment.
Responsibilities
- 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
Qualifications
- 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.