Provide expert level hands-on programming support to develop, maintain, validate programs in SAS.
Review of Statistical Analysis Plans(SAP), Annotated Case Report Forms(aCRF).
Develop/Validate ADaM/SDTM Specifications and datasets, Tables/Listing/Figures(TLFs).
Support ad-hoc statistical analyses.
Create and maintain analysis and submission datasets (ADaM, SDTM).
Generate high quality analysis datasets, data listings, tables, and graphs.
Collaborate with cross-functional departments and provide programming support.
Contribute to the preparation of presentations for internal project teams, leadership team, and external audience.

Requirements

B.Sc. / M.Sc. in Statistics, Mathematics, Computer Science, Engineering or a related field.
6 plus years of experience with SAS in pharmaceutical, biotechnology industry or CRO is required.
Strong expertise in CDISC including SDTM, ADaM, and Define.xml.
Experience in regulatory submissions (e.g., sNDA, NDA, IB and DSUR).
Excellent programming knowledge of SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH and SAS/Macro language.
Good knowledge of clinical trial design concepts.
High attention to detail, with a focus on quality and traceability in all deliverables.
Knowledge of relevant regulatory guidelines and standards (e.g., FDA, PMDA, ICH and EMA).

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SASADaMSDTMDefine.xmlSAS/BASESAS/STATSAS/SQLSAS/GRAPHSAS/Macrostatistical analysis

Soft Skills

attention to detailquality focustraceabilitycollaborationcommunication

Certifications

B.Sc.M.Sc.