Senior Programming Lead, Oncology

Johnson & Johnson Innovative Medicine•San Diego, CA

1d•$109,000 - $174,800•Hybrid

About The Position

The Senior Programming Lead, Oncology is an experienced programmer with advanced knowledge of programming languages, industry standards, complex data structures, and programming methods. The role plans and oversees one or more clinical trial programming activities of moderate to high complexity, makes decisions affecting the efficiency, timeliness, and quality of deliverables, and provides leadership and technical guidance to programming teams. The role is responsible for programming strategy and execution for clinical trials or projects, including complex clinical data analysis and reporting, and supports submission activities such as creating, verifying, and delivering CDISC-compliant or non-standard data packages and reviewer’s guides. The Senior Programming Lead works with cross-functional stakeholders and vendors, promotes consistent high-quality deliverables, and contributes to standards, innovation, and process-improvement initiatives. The position may also serve as a Delivery Unit or Disease Area Expert supporting clinical programs and submissions.

Requirements

Bachelor’s degree or higher, or equivalent, in computer science, mathematics, data science/analytics/data engineering, public health, or another relevant scientific field; equivalent theoretical or technical depth is also accepted.
At least 4 years of programming and/or clinical data management experience with increasing responsibility, preferably in a pharmaceutical or clinical trial environment.
Knowledge of programming practices, including tools and processes.
Knowledge of data structures and relevant programming languages for data manipulation, statistical analysis, and reporting; SAS knowledge is required, and languages may include SAS, R, and Python.
Knowledge of CDISC standards.
Experience planning and coordinating programming activities and leading teams.
Working knowledge of regulatory guidelines, such as ICH-GCP, and relevant clinical R&D concepts.
Demonstrated written and verbal communication skills.

Nice To Haves

Experience working with cross-functional stakeholders and teams.
Experience in vendor management oversight.
Project management skills and knowledge of team management principles.

Responsibilities

Plan programming strategy, coordinate, oversee, and execute team activities for one or more clinical trials or projects in accordance with J&J Innovative Medicine and industry standards.
Design and develop programs supporting complex clinical data analysis and reporting.
Support submissions, including creation, verification, and delivery of CDISC-compliant and/or non-standard data packages and reviewer’s guides.
Provide technical and project-specific guidance to team members to support high-quality, efficient, on-time deliverables that comply with departmental processes and procedures.
Ensure teams use current standards and technologies.
Collaborate with cross-functional teams, counterparts, and vendors to achieve project goals, and manage escalations independently.
Promote consistency and quality across trials by improving clinical data flow and implementing metadata-driven approaches.
As applicable, oversee programming outsourced to third-party vendors and use appropriate processes and practices to ensure performance meets agreed scope, timelines, and quality.
As applicable, serve as a Delivery Unit or Disease Area Expert, contributing to standards strategy and providing expertise across value streams in support of clinical programs and submissions.
Support or lead development and implementation of process, system, and tool improvements as part of departmental innovation and process-improvement projects.

Benefits

Eligibility to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to the plans’ terms.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with stated exceptions for Colorado and Washington residents.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of a child’s birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.