Senior Programming Lead, Oncology

6084-Janssen Research & Development, LLC Legal Entity; Raritan (NJ); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Programming Lead, Oncology to lead programming activities for complex clinical trials in Innovative Medicine. You will design, coordinate, and deliver SDTM/ADaM data analysis, CDISC standards compliance, and reviewer guide packages, while mentoring team members.

The role requires a Bachelor’s degree in a relevant field, 4+ years of programming/clinical data management experience, and strong communication skills.

Qualifications

• Bachelor’s degree in CS, math, data science, or related field.
• 4+ years programming and/or clinical data management in pharma/clinical trials.
• Knowledge of programming practices and data structures.
• Experience with SAS, R or Python.
• CDISC standards knowledge.
• Experience leading programming activities and teams.
• Familiarity with regulatory guidelines (ICH-GCP).
• Strong written and verbal communication.

Responsibilities

• Plan, program, coordinate, and oversee trial activities.
• Develop programs for complex data analysis and reporting.
• Support CDISC data packages and reviewer guides.
• Provide technical guidance to team members.
• Collaborate with cross-functional stakeholders and vendors.
• Oversee outsourced programming activities.

Skills

SAS Programming

Python

R

CDISC Standards

Communication skills

Project management

Education

Bachelor's degree in CS / related field

Tools

SAS

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

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, has expertise in industry standards, complex data structures and programming methods, having 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. The role makes decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables, and provides leadership, direction, and technical guidance to programming teams.

This role develops cross-functional working relationship with stakeholders to shape processes and practices and contributes expertise to Delivery Unit or departmental innovation and process improvement projects.

The Senior Programming Lead position combines the expertise and responsibilities in their respective programming roles, making them an asset to IDAR’s C&S P activities.

You will be responsible for: 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 but not limited to 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. As applicable, 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills: Preferred Skills: Advanced Analytics, Biostatistics, Clinical Trials, Collaboration, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy

The anticipated base pay range for this position is : $109,000.00 - $174,800.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year 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 the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information