Katalyst CRO ยท 2 months ago
Senior Statistical Programmer
Santa Clara, CA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is a company specializing in clinical research organization services, and they are seeking a Senior Statistical Programmer to ensure the timely and accurate delivery of statistical programming functions. The role involves managing programming activities, overseeing vendor qualifications, and providing support for clinical trial data analysis.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Ensure departmental or functional training plans in place and appropriate
Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget
Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications
Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)
Maintain complete and auditable documentation of all programming activities
Manage datasets and output across SAS programs, studies, and indications to ensure consistency
Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests
Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
Develop and/or maintain departmental procedures and standards
Review CRFs, edit check specifications, and table, figure, and listing mock-ups
Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documents
Assist in validation of SAS per 21 CFR Part 11
Train and mentor new members and programmers; supervise contract programmers, as needed
Qualification
Required
Bachelor's degree in Statistics, Mathematics, Computer Science or a related field required
Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer
Prior experience overseeing statistical programming contractors required
Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
ECTD NDA submission experience is a must
Preferred
Compound oversight experience highly preferred
Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly 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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