About this role
As a Manager, Statistical Programming, you provide statistical programming deliverables across mRNA infectious disease therapeutics programs and oversee CRO programming deliverables from study start-up through completion. You develop QC and analysis programs, review clinical study documents, and ensure submission-ready CDISC outputs (SDTM and ADaM) with audit-ready conformance.
Key Responsibilities
- Provide statistical programming deliverables across mRNA infectious disease therapeutics development programs
- Oversee CRO programming deliverables and milestones while maintaining programming standards and SOP compliance
- Review CRFs, CRF Completion Guides, Statistical Analysis Plans (SAP) and SDTM/ADaM specifications
- Independently develop Quality Control (QC) Programs and support ad-hoc requests-based analysis
- Resolve Pinnacle 21 Enterprise findings to achieve submission-acceptable conformance and audit readiness
Technical Overview
Hands-on SAS-based statistical programming for clinical trial reporting using SAS BASE, SAS SQL, SAS Macros, SAS STATS, and SAS GRAPHS. Generates and validates CDISC deliverables following FDA, EMA, and ICH guidance, including SDTM and ADaM datasets, and resolves Pinnacle 21 Enterprise findings to achieve submission-acceptable conformance.
Ideal Candidate
The ideal candidate has a Master’s degree in Statistics (or closely related field) and at least 3 years of experience as a Statistical Programmer on clinical research trials. They are strong in SAS programming (SAS BASE, SAS SQL, SAS Macros, SAS STATS, SAS GRAPHS) and can create submission-ready CDISC deliverables (SDTM and ADaM) using FDA, EMA, and ICH guidance while resolving Pinnacle 21 Enterprise findings for audit-ready conformance.
Must-Have Skills
Master's degree in Statistics or a closely related field3 years of experience as a Statistical Programmer or related position performing statistical programming for clinical research trialsUtilizing SAS languageprocedures and functions including SAS BASESAS SQLSAS MacrosSAS STATS& SAS GRAPHSApplying FDAEMA& ICH guidance to review study documents (CRFs & SAPs) and prepare submission-ready CDISC deliverables including SDTM and ADaM datasetsResolving Pinnacle 21 Enterprise findings to achieve submission-acceptable conformance and audit readinessExperience with pharmaceutical research including sponsor-side experience collaborating with CROs to oversee project deliverablesdata qualityand timelines across projects
Tools & Platforms
SASPinnacle 21 EnterpriseCDISC (submission-ready deliverables)CRFs (Case Report Forms)SAP (Statistical Analysis Plans)
Required Skills
statistical programmingSASSAS BASESAS SQLSAS MacrosSAS STATSSAS GRAPHSCDISC deliverablesSDTMADaMCRO oversightCRFsSAPsPinnacle 21 EnterpriseQC ProgramsFDA guidanceEMA guidanceICH guidanceedit check specificationsdata validation plansaudit readinessconformance
Hard Skills
statistical programming deliverablesmRNA infectious disease therapeutics development programsClinical Research Organizations (CRO) oversightstudy start-upstudy completionprogramming standardscompliance with Standard Operating Procedures (SOPs)Quality Control (QC) Programsad-hoc requests-based analysisCase Report Forms (CRFs)CRF Completion GuidesStatistical Analysis Plans (SAP)ShellsStudy Data Tabulation Model (SDTM) Annotation CRFSDTM specificationsAnalysis Data Model (ADaM) specificationsStatistical programming for clinical study reportingSAS languageSAS BASESAS SQLSAS MacrosSAS STATSSAS GRAPHSFDA guidanceEMA guidanceICH guidancesubmission-ready CDISC deliverablesCDISC deliverablesSDTM datasetsADaM datasetsPinnacle 21 Enterprise findings resolutionconformanceaudit readinessdata validation plansedit check specificationsCRF edit checksPharmacovigilance collaborationClinical Data Management collaborationClinical Operations collaborationpharmaceutical research sponsor-side experienceoverseeing CRO deliverablesdata quality managementtimeline managementtelecommute 30% of the time
Soft Skills
oversightcollaborationcross-functional communicationindependent developmentstakeholder managementdetail orientation
Keywords for Your Resume
ManagerStatistical Programmingstatistical programmingSASSAS BASESAS SQLSAS MacrosSAS STATSSAS GRAPHSClinical Research Organizations (CRO)Case Report Forms (CRFs)CRF Completion GuidesStatistical Analysis Plans (SAP)ShellsStudy Data Tabulation Model (SDTM) Annotation CRFSDTMAnalysis Data Model (ADaM)ADaMCDISC deliverablessubmission-ready CDISC deliverablesQC ProgramsQuality Control (QC) Programsad-hoc requests-based analysisFDA guidanceEMA guidanceICH guidancePinnacle 21 Enterpriseconformanceaudit readinessdata validation plansedit check specificationsSDTM datasetsADaM datasetspharmaceutical researchsponsor-side experienceSDTM and ADaM
Deal Breakers
Must have a Master's degree in Statistics (or foreign equivalent) or closely related field, Must have 3 years of experience as a Statistical Programmer performing statistical programming for clinical research trials, Must demonstrate SAS experience including SAS BASE, SAS SQL, SAS Macros, SAS STATS, and SAS GRAPHS
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