To support the Biostatistics team by carrying out and overseeing programming activities of statistical programmers and external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Supports IT related tasks including data migration, Subversion, and Varonis.
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (Client), electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. Follows Department and IT related SOPs. Determining and researching SAS software upgrades and other related systems and addressing maintenance issues. Can supports User Acceptance Testing (UAT) implementation or Proof of Concept.
3. Managing and developing team, maintaining standards for programming activities, and guiding/coaching Statistical programmers. Tracking clearly IT related activities.
4. Supports IT related activities, including UAT, SDLC, and SAS Grid implementation.
Qualifications and education required:
\" Minimum of Bachelor's degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred.
\" Minimum 2 years experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. IT background recommended.
\" Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment.
Skills and aptitude required:
\" Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. \" Varonis, Subversion, and IT background a plus. \" Proven experience with Unix and Windows operating systems. \" Understanding of the software development life cycle. \" Understanding of FDA guidelines. \" Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. \" Applies good judgment and demonstrates initiative to resolve issues. \" Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required. Python and R language desirable. Machine Learning and Deep Learning in support of Artificial Intelligence desirable.