Katalyst CRO ยท 3 days ago
Statistical Programmer I
Omaha, NE
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is seeking a Statistical Programmer I to provide SAS programming support for clinical studies. The role involves managing programming CROs, performing statistical analyses, and ensuring data integrity for regulatory submissions.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Provides SAS programming support to all clinical studies
Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables
Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
Provides primary programming and QC support for any internally produced outputs
Reviews and approves SAS programming instructions and CDISC/ADaM specifications
Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation
Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming
Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming
Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders
Assists with ensuring consistency across programming methods in similar studies within a program
Qualification
Required
Bachelor's degree or master's degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry
Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies
Experience with BLA or NDA/sNDA submissions is required
Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements
In depth knowledge of CDISC and ADaM data set structures and requirements
Proficiency with SAS programming skills to including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL) Knowledge of all aspects of clinical drug development (Phase 1-4)
Experience working with a CRO partner
Excellent computer skills; strong verbal and written communication skills
Ability to work well in a team environment as a contributor
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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