Katalyst CRO
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Principal Statistical Programmer
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Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs). Production and QC / validation programming. Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP. Demonstrate good understanding of the endpoints and data collection. Generating complex ad-hoc reports utilizing raw data. Applying strong understanding/experience of Efficacy analysis. Creating and reviewing submission documents and eCRTs. Communicating with and/or responding to internal cross-functional teams and client for project specifications, status issues, or inquiries.
Responsibilities
Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs). Production and QC / validation programming. Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP. Demonstrate good understanding of the endpoints and data collection. Generating complex ad-hoc reports utilizing raw data. Applying strong understanding/experience of Efficacy analysis. Creating and reviewing submission documents and eCRTs. Communicating with and/or responding to internal cross-functional teams and client for project specifications, status issues, or inquiries.
Requirements:
Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, or related field. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Solid experience implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis, and reporting of clinical trials' data. Submissions experience utilizing define.xml and other submission documents. Experience supporting Rare Diseases and Gastrointestinal studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. 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 Get notified about new Statistical Programmer jobs in
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Principal Statistical Programmer
role at
Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs). Production and QC / validation programming. Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP. Demonstrate good understanding of the endpoints and data collection. Generating complex ad-hoc reports utilizing raw data. Applying strong understanding/experience of Efficacy analysis. Creating and reviewing submission documents and eCRTs. Communicating with and/or responding to internal cross-functional teams and client for project specifications, status issues, or inquiries.
Responsibilities
Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs). Production and QC / validation programming. Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP. Demonstrate good understanding of the endpoints and data collection. Generating complex ad-hoc reports utilizing raw data. Applying strong understanding/experience of Efficacy analysis. Creating and reviewing submission documents and eCRTs. Communicating with and/or responding to internal cross-functional teams and client for project specifications, status issues, or inquiries.
Requirements:
Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, or related field. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Solid experience implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis, and reporting of clinical trials' data. Submissions experience utilizing define.xml and other submission documents. Experience supporting Rare Diseases and Gastrointestinal studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. 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 Get notified about new Statistical Programmer jobs in
Irvine, CA . Newport Beach, CA $165,000.00-$215,000.00 3 months ago Newport Beach, CA $205,000.00-$240,000.00 3 months ago Brea, CA $41,600.00-$62,400.00 2 weeks ago Irvine, CA $99,461.00-$128,329.00 2 hours ago Irvine, CA $50,000.00-$70,000.00 4 weeks ago Irvine, CA $70,694.00-$81,492.00 6 days ago Quantitative Research Analyst – Execution Research
Irvine, CA $186,000.00-$232,500.00 1 week ago Costa Mesa, CA $97,375.00-$120,560.00 1 day ago Data Scientist – Generative AI & Medicare Risk Adjustment Analytics
Orange, CA $149,882.00-$224,823.00 1 week ago Newport Beach, CA $110,700.00-$135,300.00 1 week ago Irvine, CA $190,000.00-$258,100.00 6 days ago Senior Applied Data Scientist – Computer Vision & Generative AI
Tustin, CA $86,917.00-$130,376.00 1 week ago United States $70,000.00-$80,000.00 5 days ago Irvine, CA $132,000.00-$189,000.00 2 days ago Orange, CA $45,000.00-$60,000.00 2 months ago SAP iXp Intern - Data Scientist, Customer and Competitive Market Intelligence
Principal Data Scientist - Sales and Marketing
Assistant Director, Student Success Dashboard Data Scientist
Irvine, CA $80,000.00-$105,000.00 3 weeks ago Software Engineer II - Data Analysis Platform
Long Beach, CA $141,000.00-$180,000.00 1 day ago Newport Beach, CA $125,000.00-$135,000.00 3 weeks ago Irvine, CA $75,000.00-$82,000.00 1 week ago Irvine, CA $70,000.00-$75,000.00 6 days ago Software Engineer II, Data Analysis Tools
Long Beach, CA $141,000.00-$180,000.00 17 hours ago Irvine, CA $71,696.00-$110,701.00 1 month ago 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