Senior Statistical Programmer

Johnson & Johnson-posted about 1 month ago

Full-time • Mid Level

Irvine, CA

5,001-10,000 employees

Chemical Manufacturing

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Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are currently recruiting for a Sr Statistical Programmer to join our team based in Irvine, CA. This role can be based in any of the J&J MedTech locations. This person will be responsible for development and generation of analysis datasets, tables, listings, and graphs from assigned clinical sources using SAS and/or R; leading development and maintenance of associated operating procedures; and participating in external industry forums (e.g., CDISC, SDTM, and relevant User Groups). This individual performs with minimal guidance on moderately difficult deliverables.

Utilize programming standards to develop efficient and accurate programs using SAS and/or R
Support creating and/or maintaining Programming Infrastructure in SAS and/or R
Support the maintenance of established SAS platform
Support the maintenance of a global SAS macro library
Support in developing and maintaining R scripts for data analysis, statistical modeling, and visualization is a plus
Keeping up-to-date with the latest R packages, techniques, and best practices is desirable
Work with Data Management leadership to provide input on reporting processes and standards
Support programming deliverables for clinical trials and support for any custom Data Management reports
Participate in the development and maintenance of global harmonized processes and procedures for programming
Provide quality programming deliverables
Work with Clinical Data Science (CDS) partners, and leadership in Clinical Operations and Franchise to set implement plans for timely delivery of reports, metrics, and study deliverables
Facilitate the delivery of standard metric reports
Ability to design, implement and maintain moderately complex programming deliverables across a wide variety of clinical platforms and thereputic areas
Participate in strategic partnerships with Clinical and Biostatistics functions at the Enterprise level to ensure MD programming practices meet the needs of the organization
Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and SDTM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine SDTM standards
Present opportunities in programming practices that increase quality of deliverables
Ensure high quality programming deliverables for clinical programs are delivered on time and in compliance to regulations and SOPs, seamlessly across all Franchises

A Bachelor's degree in Statistics , Computer Science or related discipline (required)
Minimum 4 years of system support in clinical research within Medical Device or Pharmaceuticals
Proficiency in Base SAS, SAS/STAT and SAS Macro language. Advanced SAS certification desirable. Experience in programming with R is a plus
R Programming Proficiency: Expertise in/exposure to R syntax, functions, and packages is preferred
Conduct independent QC programming and peer review of code and deliverables
Demonstrated ability work in teams to deliver critical milestones
Experience with CDISC datasets, tables , listings and figures desirable
Strong debugging, problem-solving, and documentation skills
Excellent verbal and written communication skills

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

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