Katalyst CRO · 1 month ago
Principal Statistical Programmer
Hartford, CT
Contract
Onsite
Lead/Staff
10+ years expKatalyst CRO is a company focused on providing clinical research services. They are seeking a Principal Statistical Programmer who will be responsible for writing specifications for SDTM and ADaM datasets, developing algorithms, and producing data listings and summary tables using SAS software.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets
Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets
Following specifications, develops algorithms and writes programs to create datasets
Produces data listings, summary tables and graphs using SAS software
Independently check data listings, summary tables and graphs
Imports and exports SAS data
Assists data management group in performing data edit checks
Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements
Plays an active role in taking project solutions and generalizing them for the Biostatistics group
Interact with the project statistician and guides other programmers participating on a project team
Experience with Pooled analysis, regulatory agencies requirements and e-submission experience
Qualification
Required
Minimum of 10+ years of statistical programming experience in the life science industry and relevant bachelor's degree
Must have recent NDA submissions experience
ISS/Client safety & efficacy experience is required
Experience creating define.xml and experience with Pinnacle 21 and specifications
Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS
Experience with SDTM and ADaM industry data standards
Good communication skills and attention to detail are crucial
Proven ability to handle multiple tasks
Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information
Preferred
SAS Certified Base and/or Advance Programmer experience is preferred
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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