Katalyst CRO
Clinical Statistical Programmer
Katalyst CRO - Princeton, New Jersey, us, 08543
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Overview
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Overview
Join to apply for the
Clinical Statistical Programmer
role at
Katalyst CRO 11 months ago Be among the first 25 applicants Join to apply for the
Clinical Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Generate and validate TLFs based on the Statistical Analysis Plan, TLF specifications, and industry best practices. With minimal oversight, perform all programming activities and documentation for assigned studies. Follow departmental Standard Operating Procedures (SOPs) and industry guidance to ensure traceability and regulatory compliance. Support the preparation and review of the electronic regulatory submission. Ensure that all deliverables are completed on time and of high quality. Represent the Clinical Programming function at cross-functional meetings. May support EDC development and visualization tools (PowerBI).
Responsibilities
Generate and validate TLFs based on the Statistical Analysis Plan, TLF specifications, and industry best practices. With minimal oversight, perform all programming activities and documentation for assigned studies. Follow departmental Standard Operating Procedures (SOPs) and industry guidance to ensure traceability and regulatory compliance. Support the preparation and review of the electronic regulatory submission. Ensure that all deliverables are completed on time and of high quality. Represent the Clinical Programming function at cross-functional meetings. May support EDC development and visualization tools (PowerBI).
Requirements:
Minimum 3-5 years in a clinical programming role. Bachelor's Degree (Data Science, Computer Science, Statistics, Bioinformatics, or related discipline). Independently develop SAS/R programs to generate and validate datasets according to the Statistical Analysis Plan, TLF specifications, and industry best practices. Experience generating outputs for regulatory submissions (FDA) MUST. Programming experience in SQL, JSON (Good to have). Working experience with relational databases. (EDC system, IBM (Zelta). Experience implementing CDISC standards is desirable. Knowledge of EDC development and visualization tools (PowerBI, Tableau) is an asset. Excellent Communications skills, both oral and written. Analytical skills, creativity and innovative approach to problem solving. Propensity for continuous learning and experimentation. Demonstrated initiative and problem-solving skills, critical thinking skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Statistical Programmer” roles.
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Clinical Statistical Programmer
role at
Katalyst CRO 11 months ago Be among the first 25 applicants Join to apply for the
Clinical Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Generate and validate TLFs based on the Statistical Analysis Plan, TLF specifications, and industry best practices. With minimal oversight, perform all programming activities and documentation for assigned studies. Follow departmental Standard Operating Procedures (SOPs) and industry guidance to ensure traceability and regulatory compliance. Support the preparation and review of the electronic regulatory submission. Ensure that all deliverables are completed on time and of high quality. Represent the Clinical Programming function at cross-functional meetings. May support EDC development and visualization tools (PowerBI).
Responsibilities
Generate and validate TLFs based on the Statistical Analysis Plan, TLF specifications, and industry best practices. With minimal oversight, perform all programming activities and documentation for assigned studies. Follow departmental Standard Operating Procedures (SOPs) and industry guidance to ensure traceability and regulatory compliance. Support the preparation and review of the electronic regulatory submission. Ensure that all deliverables are completed on time and of high quality. Represent the Clinical Programming function at cross-functional meetings. May support EDC development and visualization tools (PowerBI).
Requirements:
Minimum 3-5 years in a clinical programming role. Bachelor's Degree (Data Science, Computer Science, Statistics, Bioinformatics, or related discipline). Independently develop SAS/R programs to generate and validate datasets according to the Statistical Analysis Plan, TLF specifications, and industry best practices. Experience generating outputs for regulatory submissions (FDA) MUST. Programming experience in SQL, JSON (Good to have). Working experience with relational databases. (EDC system, IBM (Zelta). Experience implementing CDISC standards is desirable. Knowledge of EDC development and visualization tools (PowerBI, Tableau) is an asset. Excellent Communications skills, both oral and written. Analytical skills, creativity and innovative approach to problem solving. Propensity for continuous learning and experimentation. Demonstrated initiative and problem-solving skills, critical thinking skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Statistical Programmer” roles.
Edison, NJ $99,461.00-$128,329.00 6 days ago Branchburg, NJ $93,750.00-$200,200.00 2 weeks ago Lawrenceville, NJ $55.00-$63.00 2 days ago New Brunswick, NJ $60,000.00-$65,000.00 2 weeks ago Data Analyst with Reinsurance - Hybrid in NJ
Princeton, NJ $91,280.00-$164,280.00 7 hours ago Legal Data Analyst - Transactional & Tax Legal Data Analysis Team
Skillman, NJ $110,000.00-$150,000.00 1 week ago FSP Principal Statistical Programmer (Remote)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr