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Clinical Data Analytics & Reporting Lead

6+ years
Not Disclosed
10 July 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Analytics & Reporting Lead
Location: Mumbai/Bangalore/Hyderabad
Function: Data Analytics & Computational Sciences
Sub-Function: Biostatistics
Category: Senior Scientist, Biostatistics (ST6)
Date Posted: July 25, 2024
Requisition Number: 2406202792W

Description

At Janssen Pharmaceutical Companies of Johnson & Johnson, our mission is to create a world without disease. Achieving this goal requires advancing our data science capabilities to be at the forefront of healthcare innovation.

We are seeking a Clinical Data Analytics & Reporting Lead to join our Clinical Data Analytics & Reporting (CDA&R) team within the Clinical & Statistical Programming (C&SP) organization. This role offers a unique opportunity to be part of a team driving next-generation data and visualization strategies.

Responsibilities

  • Team Leadership: Plan, coordinate, and oversee team activities, providing technical and project-specific guidance to team members.
  • Requirement Translation: Partner with business representatives to translate clinical data needs into technical specifications and reporting/visualization solutions.
  • Programming and Data Manipulation: Perform hands-on programming and data manipulation for clinical safety review reports, visuals, and dashboards.
  • Technical Solutions Development: Design and develop technical solutions for complex clinical programming and reporting/visualization activities, including urgent requests.
  • Efficiency Improvement: Develop innovative solutions, such as macros and report/visualization templates, to enhance clinical data safety review and cleaning efficiency.
  • Stakeholder Engagement: Act as the primary delivery contact for stakeholders, providing operational oversight and project management across multiple trials.
  • Project Management: Lead project team meetings, develop detailed plans, and engage proactively in project management activities.
  • Expertise Contribution: Serve as a departmental resource and contribute to innovation and process improvement projects.
  • Training and Mentorship: Train, mentor, and coach team members while delegating tasks as needed.
  • Continuous Learning: Stay updated on industry-leading tools, technical literature, and training courses to maintain subject matter expertise in clinical data analytics/sciences.

Qualifications

  • Education: Bachelor’s degree in Computer, Data, or Life Sciences required; Master’s degree preferred.
  • Experience: 6+ years of relevant experience in the pharmaceutical industry preferred; experience in other programming roles will also be considered.
  • Knowledge: In-depth understanding of clinical drug development processes, data structures, and programming languages such as SAS, R, Python. Familiarity with complex data types like biomarkers and digital data (ECG, imaging) is a plus.
  • Tools Proficiency: Experience with report writing, analytics, and visualization tools (e.g., Spotfire, Tableau, Qlik, JReview) is strongly preferred.
  • Standards and Guidelines: Demonstrated understanding of CDISC requirements and implementation guidelines preferred.
  • Project Management: Experience in planning, coordinating, and managing team activities; project management skills required.
  • Communication: Strong written and verbal communication skills.
  • Learning and Adaptation: Aptitude to learn modern technologies and make recommendations for their use.
  • Vendor Management: Experience in vendor management oversight is required.

Equal Opportunity Employer

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. We evaluate all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and do not discriminate based on disability.