Principal Progr-Stat Progr

Principal Programmer, Statistical Programming Northern, NJ (Onsite or Remote)
Responsibilities

• Perform SAS data processes and analysis programming.
• Work with Statistician and Statistical programmer to assure results are consistent with expectations, and quality control procedures are followed.
• Lead the development and delivery of training.
• Act as primary contact to ensure company standards are implemented in all studies.
• Work collaboratively to meet study deliverables and timelines for statistical data analysis and reporting.
• Plan and carefully document differences between programming results between program developer and Statistical QC programmer.
• Provide programming support on ISS/ISE and post-submission activities.
• Provide flexible and rapid responses to programming requests.
• Ensure consistency and adherence to standards within the project.
• Confirm that tracking sheets are current for projects and results are consistent with earlier generated results.
• Maintain up-to-date study documentation.
• Identify opportunities to improve methodology and provide practical solutions for problems.
• Develop, program, test, and maintain computer validation/edit checks in SAS.
• Validate peer programming.
• Provide technical expertise and support to the Data Management team.
• Routinely interface with cross-functional team members.
• Participate in regular team meetings and provide input when appropriate.
• Participate in the development of clinical programming SOPs and optimize clinical programming processes from study start-up to database lock.
• Manage project priorities and timelines.
• Review programming activities and costs in contracts.
• Direct responsibility for supervising and training junior clinical programmers.

• B.S. degree or higher in programming or statistics.
• Minimum of 5 years of SAS experience in pharmaceutical or equivalent.
• Understanding of GCP, ICH, and FDA guidelines and regulations applicable to clinical research.
• Knowledge of CDISC standards and industry best practices.
• Strong SAS programming, macro development, and SAS graph skills.
• Good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards, and protocol designs.
• Excellent oral and written communication skills for cross-site and cross-function collaboration.
• Dependable, motivated, focused, and detail-oriented.
• Ability to take direction as needed and work independently on projects when necessary.
• Capable of managing time effectively and adhering to timelines and project schedules.
• Working knowledge of SAS modules and utilities.
• Ability to develop routines using the SAS Macro Language.
• Understanding of biotech industry regulatory requirements.
• Ability to use Microsoft Office tools (Word, Excel, PowerPoint).