Associate Director, Statistical Programming
MindMed
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $175,000 - $199,777 per year
Job Level
About the role
- 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
Requirements
- 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.
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SASstatistical programmingdata validationDefine XMLCDISC standardsstatistical analysisdata managementPinnacle 21PROC FreqPROC GLM
Soft skills
collaborationorganizational skillsproject managementdetail-orientedcommunicationinterpersonal skillsteam playeradaptabilityproblem-solvingtime management
Certifications
Master's Degree in BiostatisticsMaster's Degree in StatisticsMaster's Degree in Computer Science