Job DescriptionSponsor-dedicated:Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer, you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
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.
ResponsibilitiesHow you will contribute:- 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
QualificationsHere at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: - 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.
