As Associate Director, Statistical Programming, this role will provide statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization. Reporting to Director, Statistical Programming Lead, this role will serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed. Working with the study lead biostatistician, this individual will oversee the deliverables from statistical vendors to ensure high quality and meeting timelines. Additionally, this role will perform statistical data analyses and partner with the Clinical Data Management group to support data cleaning activities.

Responsibilities:

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
• Review and ensure high quality of Define packages for integrated datasets from meeting CDISC standards to meeting regulatory requirements as part of electronic submission
• Work closely with study lead biostatistician to manage vendor’s deliverables from quality to timeline
• Perform independent validation (QC) to ensure accuracy of statistical vendor’s deliverables from datasets to analytic outputs
• Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
• Review CRF and/or Data Transfer Specification to ensure that data collection will meet the study objectives, requirements, and standards in CDISC format
• Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures
• Perform statistical analysis to support publications, and/or regulatory correspondence as needed
• Perform other duties as assigned

Qualifications and Skills:

• Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 12 years of experience in providing statistical programming support in clinical trial setting
• Deep understanding about data standards with rich experience in understanding Pinnacle 21 validation report and creating Define XML packages to support regulatory filing
• Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED)
• Demonstrated capacity of collaboration with biostatisticians, Clinical Data Management and colleagues from other functions to deliver common goals
• Strong organizational and project management skills demonstrated interest in continued learning and growing
• Proven to work well on multiple projects in a fast-paced environment
• Detail-oriented and hold high standards of excellence for Statistical Programming’s deliverables
• Deliver and communicate effectively in the work-from-home environment
• Excellent interpersonal skills and a good team player

Preferred Experience:

• Experience in data structure and data analysis in CNS clinical trials
• Experience in providing integrated data analysis support in regulatory filing