POSITION OBJECTIVE: Provide accurate, efficient and effective programming solutions required for clinical trial analysis and reporting. Perform a wide range of activities that include: understanding study protocols, study designs and SAP; creation of complex datasets, tables, listings and figures using SAS; follow and validate CDISC standards; perform basic quality-checklist code reviews; develop standardized programs to automate routine tasks; design, write and debug macro routines. Collaborate closely and communicate clearly with project team members of other functions. Work with minimal supervision of statistical programming lead. Exercise good judgment in interpreting, modifying and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
Essential Job Functions/Responsibilities
- Develop, validated, debug and execute programs and macro routines.
- Proficiently create datasets, tables, listings and figures, based upon study protocols, data analysis plans, dataset specifications and CDISC standards.
- Understand complicated study designs, disease states, and dataset structures.
- Validate results produced by external vendors and/or internal staff, as appropriate. Ensure data compliance by following the established guidelines of national and international regulatory authorities.
- Recognize anomalies in data and program output and communicate this information effectively.
- Ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
- Provide input and support on data and submission standards to study teams to ensure high quality and timely eSub deliverables that meet industry standards and regulatory requirements.
- Perform adhoc/exploratory data analyses based on requirements provided by statistician or specified in analysis plans.
- Provide statistical programming representation on study teams.
- Provide project deliverable oversight, mentorship to junior programmers and keep track of time lines.
- Identify routine problems; provide recommendations based upon analysis of the situation for assigned projects.
- Develop and validate standard macros, template programs and/or tools in SAS for data analysis and reporting.
- Review edit check specifications and provide comments to study data manager.
- Remain informed of new developments in programming that are relevant to the industry. Evaluate and implement new technologies and processes as appropriate.
Required Education & Qualifications
- Bachelor or MS degree in relevant scientific majors.
- 4 plus years of SAS programming experience in the pharmaceutical industry as a Statistical SAS Programmer. SAS Certification desirable.
- Good SAS (Base/Graph/STAT) and SAS macro programming skills with ability to provide quality output and deliverables for safety and efficacy (ISS/ISE).
- Familiar with CDISC SDTM/ADaM standards, medical terminology, and clinical trial methodologies.
- Strong experience in QC / validation skills.
- Strong understanding of relational database structure.
- Demonstrate teamwork and interpersonal skills with strong verbal and written communication skills in a global environment.
- Knowledge of pharmaceutical clinical development life cycle (i.e. understanding safety deliverables, efficacy analysis).
- Excellent organizational skills with ability to support multiple assignments with challenging timelines.
- Excellent analytical, problem solving and troubleshooting skills that demonstrate initiative and motivation.
- Knowledge of statistical tests and procedures and ability to apply them effectively.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.