Cytel
Join us in a pivotal role as a Senior Statistical Programmer, where you'll be embedded within a leading global pharmaceutical client and supported by the dynamic team at Cytel. This position offers a unique opportunity to contribute to innovative patient treatments while working in a collaborative environment that values ownership and autonomy.
Position Overview:
As a Senior Statistical Programmer, you will utilize your advanced SAS programming skills and expertise in CDISC standards (SDTM & ADaM) to support or lead clinical trials at various stages. This role is hybrid office-based in Pennsylvania (Preferred) or New Jersey.
What You'll Do:
Generate and validate statistical programming deliverables including SDTM, ADAM, and TFLs across Early Development Statistics and PK/PD Modeling and Simulation.
Perform data manipulation, analysis, and reporting for clinical trial data, focusing on both safety and efficacy outcomes (ISS/ISE).
Utilize SAS programming for production and quality control/validation.
Create complex ad-hoc reports using raw data.
Contribute to the development and review of submission documents and electronic Case Report Tabs (eCRTs).
Communicate effectively with internal cross-functional teams and clients regarding project specifications, statuses, and inquiries.
Take on lead responsibilities when necessary and demonstrate a collaborative spirit to achieve project goals.
Adapt easily to changing priorities and handle shifting timelines with professionalism.
At Cytel, we are dedicated to your success and provide continuous training, development, and support.
Qualifications:
Bachelor's degree in Statistics, Computer Science, Mathematics, or a related field.
At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry, or a minimum of 6 years with a master's degree or higher.
Proven experience in Early Development studies and programming clinical endpoint data (efficacy and safety) and pharmacokinetic data.
Capacity to develop and validate global programming standards for ADaM datasets and efficacy/safety analysis.
Familiarity with programming algorithms, preferably in R, SPlus, or NonMem.
Experience in creating SDTM deliverables for analyses and submissions, supporting project teams to prepare necessary submission documents, including Pinnacle 21 Enterprise.
Knowledge of the latest CDISC SDTM / ADaM standards and submission standards (Define.XML, SDRG, aCRF).
Strong QC/validation skills and analytical problem-solving capabilities.
The ability to deliver high-quality outputs under tight deadlines while working effectively in a globally dispersed team environment.
If you are ready to make an impact in the world of clinical trials, we encourage you to apply!
Cytel Inc. is an Equal Employment / Affirmative Action Employer and considers all applicants for positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.