At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

Job Function

Data Analytics & Computational Sciences

Job Sub Function

Biostatistics

Job Category

Scientific/Technology

All Job Posting Locations:

IN004 Bangalore, IN020 Mumbai Arena Space, IN022 Hyderabad

Job Description

Principal Responsibilities:

• Designs and develops statistical programs in support of clinical research analysis and reporting activities.
• Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities.
• Maintains statistical programming documentation as appropriate.
• Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.
• Performs activities in compliance with departmental processes and procedures.
• Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals.
• Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables.
• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.
• May contribute to departmental innovation and process improvement projects.
  
  

Principal Relationships

• Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities
• Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical – Primary interfaces within clinical project (trial), program, and submission teams.
• External contacts include but are not limited to external partners including CROs.
  
  

Qualifications - External

• Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth).
• Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field.
• In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred.
• Working knowledge of processes and concepts relevant to Statistical Programming.
• Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.
• Demonstrated written and verbal communication skills.
• Experience working in a team environment.