Reporting to the Head of Statistical Programming, the individual will be responsible for establishing plans and strategies for the system planning, initial setup, implementations, enhancements, change control, and ongoing support for Biometrics systems and tools in collaboration with internal staff, vendors, QA, and IT. In addition, he/she will be responsible for setting up the programming standards, processes and documentation so that Base SAS, SAS graphs and SAS Macros can be shared and re-used by others easily.
Primary Responsibilities include:
- Act as liaison between Biostatistics, Statistical Programming, QA, IT and other functional area for evaluating new systems or upgrades to the existing systems and software such as SAS Server related to Biometrics function.
- Coordinate with QA, IT and other functional area for user requirements, validation plan, system design specification, and IQ/OQ/PQ.
- Manage folder structure and folder level permissions for each project/study for data contained within these systems.
- Create and maintain SOPs, user guidance/documentation and training materials.
- Work with various stakeholders such as Data Management, Clinical Operations, CROs etc. to harmonize specifications, requirements and receipt of external data transfers.
- Support the development, programming and maintenance of data, tools and processes for the Sarepta data lifecycle and business integrity.
- Monitor systems for disk space, CPU usage and other parameters for optimal and efficient operation of the system.
- Provide day-to day user and technical support, open, monitor, and close all incident calls related to Sarepta Biometrics systems and tools.
- Create programming standards and documentation such as rules for naming conventions, compatibility, appearance, efficiency, and maintainability for promoting Good Programming Practices.
- Identifies problems, and develops/maintains global tools/utilities that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
Education and Skills Requirements:
- Master Degree in statistics, computer science or a related field with at least 8 years (or BS in statistics, computer science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry.
- Strong understanding of the software development lifecycle and computer system validation concepts.
- Overall project management and planning activities for smaller projects and all business aspects of the requirements and analysis phase of larger projects. Able to perform requirements gathering and analysis.
- Prior experienceworking with controlled statistical computing environment for supporting the analytical needs of statistical programming and biostatistics.
- Strong understanding of receipt or access of clinical trial data from variety of system/sources such as the CDMS/RDC/EDC system, CROs, central and specialty labs, or other external data vendors.
- End-to-end experience in development of SDTM or tabulation datasets, ADaM or analysis datasets, tables listings and graphs (TLGs), and submission components for all deliverables whether for CSRs, ad hoc analysis.
- Excellent skills in SAS programming and statistical reporting. Experience with other programming languages desirable.
- Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO-DD.
- Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA).
- Experience with FDA and ICH regulations and guidelines.
- Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
- Demonstrate excellent leadership and communication skills.
- Excellent written and verbal communication skills and organizational and documentation skills.
- Ability to work on a multidisciplinary team that may include Biostatistics, Quality Assurance, IT etc.
- Demonstrated positive attitude and the ability to work well with others.