Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must
Cytel
Summary
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. This role is Hybrid office based in PA (Preferred) OR NJ.
Job description
Position Overview
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. This role is Hybrid office based in PA (Preferred) OR NJ.
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/ISE), utilizing SAS programming
- Production and QC / validation 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
Qualifications
- 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.
- 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).
- 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.
- Experience in one or more of the following will be preferred: R, SPlus, NonMem.
- 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.
- Up-versioning activities to specific versions of SDTM.
- Experience supporting Oncology studies would be a plus.
- 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.
- Strong QC / validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- 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.
- 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.
Requirements
- Bachelor’s degree in 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
- 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)
- 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
- Experience in one or more of the following will be preferred: R, SPlus, NonMem
- 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
- Up-versioning activities to specific versions of SDTM
- Experience supporting Oncology studies would be a plus
- 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
- Strong QC / validation skills
- Good ad-hoc reporting skills
- Proficiency in Efficacy analysis
- 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
- 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
Company overview
Cytel is a global leader in data-science contract research organization (CRO) services, specializing in advanced statistical analytics and innovative clinical trial software solutions. Founded in 1987 and headquartered in Cambridge, Massachusetts, the company has established itself as a pioneer in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. With over 2,000 employees across North America, Europe, and Asia, Cytel provides comprehensive services ranging from innovative trial design to end-to-end biometrics and real-world evidence solutions. The company's mission focuses on accelerating drug development, enhancing success rates, and delivering better patient outcomes through robust analytics and specialized multidisciplinary expertise. Cytel's software products, including the East Horizon platform and StatXact statistical software, are widely used by major biopharmaceutical companies and regulatory agencies worldwide, supporting the design, simulation, and monitoring of adaptive clinical trials.