Katalyst CRO
Overview
Sr. SAS Programmer
role at
Katalyst CRO . Responsibilities
Prepare data for state-of-the-art analysis, such as PPK, PKPD, exposure-response (efficacy or safety), and C-QTc, typically based on CDISC ADaM / SDTM datasets. Prepare data for state-of-the-art NCA analysis, such as ADPC, PP, and ADPP, including the creation of defined packages and reviewer guides. Write, maintain, and develop high-quality Programs and Macros (R, SAS) to facilitate the construction of analysis datasets and P21 validations. Interact with members of the multidisciplinary team to establish project timelines; computerized data validation checks and ad hoc requests. Design and implement statistical algorithms and code in conformance with defined programming processes and standard operating procedures. Conduct exploratory analyses of PKPD data in support of modeling analyses. Write statistical analysis plan and perform exposure-analysis on QTc as requested. Following completion of the project deliverables, you are responsible for the creation of an electronic submission package for future submission to regulatory agencies. Requirements
BS, MSc, Master in Statistics, Mathematics, PhD, PharmD, or related fields. About 5 years' experience and expertise in PKPD programming and analysis, report writing, and regulatory drug submissions. General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology. Expertise in PK/PD programming with strong quantitative skills applied to develop PPK, PKPD, ER-efficacy, ER-safety, and C-QTc datasets. Expertise in software used for dataset construction (e.g. R, SAS). Strong track record of working in various therapeutic areas. Familiarity with regulatory requirements and trends with respect to data standards. Details
Seniority level: Associate Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing
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Sr. SAS Programmer
role at
Katalyst CRO . Responsibilities
Prepare data for state-of-the-art analysis, such as PPK, PKPD, exposure-response (efficacy or safety), and C-QTc, typically based on CDISC ADaM / SDTM datasets. Prepare data for state-of-the-art NCA analysis, such as ADPC, PP, and ADPP, including the creation of defined packages and reviewer guides. Write, maintain, and develop high-quality Programs and Macros (R, SAS) to facilitate the construction of analysis datasets and P21 validations. Interact with members of the multidisciplinary team to establish project timelines; computerized data validation checks and ad hoc requests. Design and implement statistical algorithms and code in conformance with defined programming processes and standard operating procedures. Conduct exploratory analyses of PKPD data in support of modeling analyses. Write statistical analysis plan and perform exposure-analysis on QTc as requested. Following completion of the project deliverables, you are responsible for the creation of an electronic submission package for future submission to regulatory agencies. Requirements
BS, MSc, Master in Statistics, Mathematics, PhD, PharmD, or related fields. About 5 years' experience and expertise in PKPD programming and analysis, report writing, and regulatory drug submissions. General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology. Expertise in PK/PD programming with strong quantitative skills applied to develop PPK, PKPD, ER-efficacy, ER-safety, and C-QTc datasets. Expertise in software used for dataset construction (e.g. R, SAS). Strong track record of working in various therapeutic areas. Familiarity with regulatory requirements and trends with respect to data standards. Details
Seniority level: Associate Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr