Katalyst CRO
Responsibilities
Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas. Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), utilizing SAS programming. 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. Performing lead duties when called upon. Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change. Develop and validate global programming standards for ADaM datasets. Develop and validate global programming standards for efficacy analysis, safety analysis and reporting. Design and develop complex programming algorithms. Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission. Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise. Requirements
Bachelor's degree in Statistics, Computer Science, Mathematics, or related field. At least 8 years of SAS programming experience 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. As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late stage clinical trials. Having experience/expertise working on Early Development studies. Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters). Up-versioning activities to specific versions of SDTM. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF. Submissions experience utilizing Define.XML and other submission documents. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. Seniority level
Associate Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x
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Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas. Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), utilizing SAS programming. 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. Performing lead duties when called upon. Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change. Develop and validate global programming standards for ADaM datasets. Develop and validate global programming standards for efficacy analysis, safety analysis and reporting. Design and develop complex programming algorithms. Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission. Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise. Requirements
Bachelor's degree in Statistics, Computer Science, Mathematics, or related field. At least 8 years of SAS programming experience 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. As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late stage clinical trials. Having experience/expertise working on Early Development studies. Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters). Up-versioning activities to specific versions of SDTM. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF. Submissions experience utilizing Define.XML and other submission documents. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. Seniority level
Associate Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x
#J-18808-Ljbffr