Statistical Programming Lead

Johnson & Johnson Innovative Medicine•Ambler, PA

About The Position

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. 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 Statistical Programming Lead, located in Spring House, PA, Titusville or Raritan, NJ. Purpose: The Statistical 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 (Integrated Data Analytics & Reporting) C&SP (Clinical and Statistical Programming) activities. You will be responsible for:

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 programming and or clinical data management experience with increasing responsibility in pharmaceutical/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 such as SAS and R experience are required.
Experience working with cross functional stakeholders and teams.
Project management skills and knowledge of team management principles.
Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts are required.
Demonstrated written and verbal communication skills.

Nice To Haves

Python is preferred.
Expert CDISC Standards knowledge is preferred.
Experience in planning and coordinating programming activities and leading teams.
Experience in vendor management oversight will be nice to have.

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.
Ensures the utilization of latest standards and technologies, adhering to regulatory requirements, and creating effective mapping algorithms and Data Review Model (DRM) and designs mapping algorithms for non-standard conversions as needed.
Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
annual performance bonus