POSITION OBJECTIVE: Provide efficient and effective programming solutions required for clinical pharmacology data analysis and reporting, including understanding clinical pharmacology components of study protocols, creation of more complex and integrated datasets, creation of graphs using more advanced programming skills, understanding and application of more advanced statistical tests, perform basic quality-checklist code reviews, develop standardized programs to automate routine tasks; and design, write and debug macro routines.
This position will be located in either our Buffalo, New York office or our Cranford, New Jersey office.
Essential Job Functions/Responsibilities
- Provide clinical pharmacology statistical representation on project and protocol teams.
- Participate in the protocol development process, including sample size calculations and the statistical analysis plan section of the protocol.
- Perform bioequivalence (including food-effect, DDI, etc.) analysis and ad hoc statistical analyses, when needed.
- Preparation clinical pharmacology data analysis plans, tables, figures and listings for inclusion in clinical reports.
- Perform exploratory data analyses based on requirements provided by scientists or specified in analysis plans. The results from exploratory data analyses may be used for further data characterization, such as logistic regression or time-to-event analyses.
- Develop, validate and execute programs and macro routines. Proficiently create complex datasets, tables, listings, and figures, based upon study protocols, data analysis plans, dataset specifications and CDISC (SDTM, ADaM) standards.
- Understand complicated study designs, disease states and dataset structures.
- Understand and apply the concept of data disposition to datasets created.
- Validate results produced by external vendors and/or internal staff, as appropriate.
- Provide input and support on data and submission standards to project teams to ensure high quality and timely deliverables that meet industry standards and regulatory requirements.
- Participate in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines. Ensure data compliance by following the established guidelines of national and international regulatory authorities
- Collaborate closely, mentor and communicate clearly with project team members of the Biostatistics, Data Management, Clinical Pharmacology and Regulatory departments on various clinical projects.
- Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
Required Education & Qualifications
- Minimum of Master of Science degree in Statistics or related field.
- Minimum of 5 years of experience as a Clinical/Statistical SAS Programmer in the pharmaceutical, or related, industry. SAS Certification desirable.
- Strong SAS (Base/Graph/STAT) and SAS Macro programming skills with understanding and experience preferably in a clinical data environment.
- Proficient in industry standards (CDISC), relational database structure, medical terminology, and clinical trial methodologies.
- Knowledge of pharmaceutical clinical development (i.e., understanding safety deliverables, clinical pharmacology concepts, efficacy analysis) and ability to provide programming support needs for regulatory submissions.
- Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
- Demonstrated teamwork, organizational, innovative problem-solving and interpersonal skills required; strong verbal and written communication skills in a global environment is also necessary for success.
- Able to work independently, exercise judgment in interpreting, modifying and adapting procedures, practices, methods, etc.
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.