Job Description
How will you make an impact?
The Sr. Statistical Programmer II functions as the lead programmer for assigned clinical studies, who coordinates and oversees the statistical programming activities, such as generating SDTM/ADaM datasets and statistical outputs (TLFs), to support statistical analyses in regulatory submissions, post-marketing, and publications.
What will you do?
- Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with statisticians and other clinical team members to ensure programming requirements are understood.
- Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.
- Managing/coordinating resources on study basis to ensure high-quality and on-time deliverables of statistical analyses.
- Capable of developing the written specifications based on SDTM/ADaM Implementation Guide and creating programs to produce CDISC-compliant SDTM/ADaM datasets and define.xml files.
- Generate tables, figures, and listings, (TFLs) in accordance with TFL shells to support analyses using
- Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology.
- Capable of validating SAS programs, macros, datasets, and TFL output generated by other programmers.
- Ensure consistency across programming methods in similar studies within a project.
- Contribute to requests for proposals for programming services from outsourcing vendors. Provide oversight and monitor progress of vendors working on sponsored studies. Develop or assist in the development of departmental processes and procedures.
- Other duties as assigned.
How will you get here?
- Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required
- BA/BS degree and a minimum of 8 years of related
- Advanced degree preferred
- High proficiency in SAS programming and Macro development
- Experience working with CDISC SDTM and ADaM compliant data sets
- Experience with regulatory submissions.
- Experience programming supporting integrated analyses, e.g. ISS, ISE.
- Good Knowledge of statistics and the drug development process
- In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices
- Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
- Solid verbal and written communication skills
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
