Katalyst CRO ยท 1 month ago
Clinical SAS Programmer
Edison, NJ
Contract
Onsite
Senior LevelKatalyst CRO is a clinical research organization seeking a Clinical SAS Programmer to manage and oversee statistical programming resources. The role involves ensuring the quality and timely delivery of statistical programming deliverables for clinical trials while collaborating with study teams and adhering to regulatory specifications.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications
Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc
Ensure timely delivery of all statistical deliverables for each study assigned
Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items
Follow departmental SOPs and processes for operational excellence
Lead statistical programming activities for regulatory submissions following CDISC standards
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan
Take ownership for the completion of SDTM and ADAM specifications for assigned studies
Qualification
Required
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Strong SAS programming and graphic programming skills
Able to guide the successful completion of major programs and projects
Strong analytical and communication skills
Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology in relevant therapeutic areas
Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses
Experience in management of CROs with respect to statistical programming
Preferred
Experience with BLA or NDA/sNDA to FDA/EMA is preferred
Experience with other major global health authority submission is a plus
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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