ASSOCIATE DIRECTOR

Job Description

This is a new opportunity!If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, this is for you!

The Associate Director of Clinical Programming will function as the leader of the Clinical Programming group within Clinical Data Management. This position will work collaboratively with data managers, clinicians, trial managers, biostatisticians, and statistical programmers in the planning, conduct, and execution of all phases of clinical studies. This position will also develop and maintain a clinical programming infrastructure consistent with and supportive of current and future process developments.

Essential Functions

• Lead, manage, coach, develop, and support the Clinical Programming group within Clinical Data Management
• Identify and execute on strategy and enable and ensure the quality of Clinical Programming deliverables
• Manage multiple complex projects and assess time and resource estimates/projections for project planning and workflow management for the Clinical Programming group
• Understand SAS programming concepts and techniques and other emerging programming tools specific to the pharmaceutical industry and proactively correct limitations in the company's current strategy
• Has excellent SAS Programming skills, and is able and willing to work hands on (study level programming support) if necessary
• Create/Update SAS Programming standards, SOPs, and Work Instructions for the programming group as well as for end-users of deliverables as necessary
• Represent the Clinical Data Management department in building solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders
• Participate in the development and implementation of clinical data standards and lead the development of standard review tools related to clinical data, clinical data review, and risk-based trial management

Required Knowledge, Skills, and Abilities

• Excellent verbal and written communication skills across all functional areas.
• Excellence in programming with SAS. Knowledge of additional programming languages a plus.
• Extensive knowledge of SAS macro writing and usage
• Experience as a clinical programmer in supporting data review and trial metrics production
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests
• Experience with management of direct reports in a corporate environment
• Experience leading and implementing strategic improvements in clinical programming preferred
• Experience overseeing the work of internal contractors and external vendors (CROs)
• Extensive knowledge of CDISC standards, including CDASH and SDTM
• Understanding of the drug development process and risk-based trial management concepts

Qualifications

• Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields.
• Minimum of 10 years of experience in developing and programming software in a clinical trial environment using the SAS system.
• Minimum of 3 years of supervisory experience.
• Knowledge of clinical analytics systems a plus.

Additional Information

Occassional travel. Must be available to work onsite as needed when the office reopens.Competitive salary. Comprehensive benefits. Relocation assistance available for the selected candidate.