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 one of the following fields Statistics, Computer Science, Mathematics, etc.
• 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.
• 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.

• 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