Location North Wales, Pennsylvania, United States of America. Full‑time position.
This position supports statistical programming activities for late‑stage drug and vaccine clinical development projects, including leadership of one or more projects. The incumbent develops and executes statistical analysis and reporting deliverables such as safety and efficacy analysis datasets, tables, listings, and figures, ranging from individual clinical trials to worldwide regulatory submissions and post‑marketing support.
The role designs and maintains statistical datasets for multiple stakeholders, collaborates with statistics and other project stakeholders to ensure efficient execution of project plans, and serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle.
Responsibilities- Apply state‑of‑the‑art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines.
- Support statistical programming activities for late‑stage drug/vaccine clinical development projects, including leading one or more projects.
- Develop and execute statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for trials, regulatory submissions, and post‑marketing support.
- Design and maintain statistical datasets that support clinical development, outcomes research, and safety evaluation.
- Collaborate with statistics and other project stakeholders to ensure timely, high‑quality deliverables.
- Provide SAS programming support for clinical trials from Phase I through Phase III.
- Use the CDISC Analysis Data Model (ADaM) and SDTM data to develop analysis datasets programmatically.
- Write code for Tables, Listings and Figures (TLF) macros and implement statistical methodologies.
- Generate TLFs as per the statistical analysis plan.
- Maintain and manage a project plan, including resource forecasting.
- Coordinate activities of a global programming team, including outsourced staff.
- Support NDA/BLA submissions and address agency questions as required.
- Mentor junior programmers and collaborate with third‑party vendor programs.
- Part‑time telecommuting permitted.
- Up to 10 % domestic travel required.
Requirements
- Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with 5 years of experience in a similar SAS programming role within a clinical trial environment, or Master’s degree with 3 years of experience.
- At least 3 years of experience with SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH, systems, and databases.
- Experience designing and developing complex programming algorithms.
- Ability to interpret analysis plans and translate methodology into code.
- Knowledge of statistical terminology and concepts; understanding of clinical data management concepts; familiarity with CDISC and ADaM standards.
- Ensuring process compliance and deliverable quality.
- Designing statistical databases that optimize analysis and reporting.
Location
351 N Sumneytown Pike, North Wales, PA 19454
Salary$117,000 – $184,200 per year
BenefitsEmployees receive a comprehensive benefits package that includes medical, dental, and vision insurance (for employee and family), retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days. Eligibility for annual bonus and long‑term incentive, where applicable.
EEO StatementWe are an Equal Employment Opportunity Employer that provides equal opportunities to all employees and applicants for employment and prohibits discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. We adhere to the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring Ordinance and consider qualified applicants with arrest and conviction records in compliance with applicable local laws.
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