Associate Director, Statistical Programming
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Associate Director, Statistical Programming provides statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization. This role serves as the study lead programmer for assigned clinical trial(s), collaborating with the study statistician, data management, and other study team members to deliver high-quality programming support and ensure timely delivery. The role oversees vendor deliverables, performs statistical analyses, and partners with Clinical Data Management to support data cleaning activities. Responsibilities
Serve as the study lead programmer for assigned clinical trial(s), collaborating with the study statistician, data management, and other study team members to provide statistical programming support as needed Review and ensure high quality 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 Define packages for integrated datasets meeting CDISC standards for regulatory submission Work closely with the study lead biostatistician to manage vendor deliverables from quality to timeline Perform independent validation (QC) to ensure accuracy of statistical vendor deliverables from datasets to analytic outputs Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers Collaborate with Clinical Data Management to produce systematic data reports supporting data review and cleaning Review CRF and Data Transfer Specification to ensure data collection meets study objectives and standards in CDISC format Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures Perform statistical analyses to support publications and regulatory correspondence as needed Perform other duties as assigned Qualifications
Required:
Master's Degree in Biostatistics, Statistics, Computer Science or related field with at least 12 years of experience providing statistical programming support in a clinical trial setting Required:
Deep understanding of data standards with experience in Pinnacle 21 validation and creating Define XML packages to support regulatory filing Required:
Proficiency in SAS, including complex data steps, SAS macro language, and common procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED) Required:
Demonstrated ability to collaborate with biostatisticians, Clinical Data Management, and others to achieve goals Required:
Strong organizational and project management skills with a commitment to continuous learning Required:
Ability to manage multiple projects in a fast-paced environment Required:
Detail-oriented with high standards for deliverables Required:
Effective communication in a work-from-home environment and strong interpersonal skills Required:
Good teamwork and collaboration skills Education
Master's Degree in Biostatistics, Statistics, Computer Science or other relevant field
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Associate Director, Statistical Programming provides statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization. This role serves as the study lead programmer for assigned clinical trial(s), collaborating with the study statistician, data management, and other study team members to deliver high-quality programming support and ensure timely delivery. The role oversees vendor deliverables, performs statistical analyses, and partners with Clinical Data Management to support data cleaning activities. Responsibilities
Serve as the study lead programmer for assigned clinical trial(s), collaborating with the study statistician, data management, and other study team members to provide statistical programming support as needed Review and ensure high quality 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 Define packages for integrated datasets meeting CDISC standards for regulatory submission Work closely with the study lead biostatistician to manage vendor deliverables from quality to timeline Perform independent validation (QC) to ensure accuracy of statistical vendor deliverables from datasets to analytic outputs Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers Collaborate with Clinical Data Management to produce systematic data reports supporting data review and cleaning Review CRF and Data Transfer Specification to ensure data collection meets study objectives and standards in CDISC format Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures Perform statistical analyses to support publications and regulatory correspondence as needed Perform other duties as assigned Qualifications
Required:
Master's Degree in Biostatistics, Statistics, Computer Science or related field with at least 12 years of experience providing statistical programming support in a clinical trial setting Required:
Deep understanding of data standards with experience in Pinnacle 21 validation and creating Define XML packages to support regulatory filing Required:
Proficiency in SAS, including complex data steps, SAS macro language, and common procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED) Required:
Demonstrated ability to collaborate with biostatisticians, Clinical Data Management, and others to achieve goals Required:
Strong organizational and project management skills with a commitment to continuous learning Required:
Ability to manage multiple projects in a fast-paced environment Required:
Detail-oriented with high standards for deliverables Required:
Effective communication in a work-from-home environment and strong interpersonal skills Required:
Good teamwork and collaboration skills Education
Master's Degree in Biostatistics, Statistics, Computer Science or other relevant field
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