Senior Programming Lead, Oncology

About Innovative Medicine

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We are searching for the best talent for a Senior Programming Lead, Oncology.

Purpose

The Senior Programming Lead is an experienced programmer with an advanced knowledge of programming languages, expertise in industry standards, complex data structures and programming methods, with the technical capabilities in leading trial activities in accordance with departmental processes and procedures. This role is responsible for providing expertise, planning and oversight of one or more programming trial activities of moderate to high complexity, makes decisions and recommendations that impact efficiency, timeliness, and quality of deliverables, and provides leadership, direction, and technical guidance to programming teams.

Principal Responsibilities

• Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects.
• Designs and develops programs in support of complex clinical data analysis and reporting activities.
• Supports submission activities including creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer's guides.
• Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures.
• Ensures use of latest standards and deployment of current technologies.
• Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently.
• Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.
• Oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
• May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.
• Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes, systems, and tool improvement initiatives.

Qualifications / Requirements

• Bachelor's degree or higher and/or equivalent in computer science, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth).
• 4+ years experience programming and/or clinical data management experience with increasing responsibility preferably in pharmaceutical/clinical trial environment is required.
• Knowledge of programming practices (including tools and processes) is required.
• Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting is required. May include SAS, R, Python, etc.
• Knowledge of SAS is required.
• CDISC Standards knowledge is required.
• Experience in planning and coordinating programming activities and leading teams is required.
• Experience working with cross functional stakeholders and teams is preferred.
• Experience in vendor management oversight is preferred.
• Project management skills and knowledge of team management principles is preferred.
• Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts is required.
• Demonstrated written and verbal communication skills is required.