Clinical Programming Lead

6+ years

Not Disclosed

Bangalore Hyderabad Mumbai

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

Job Title: Clinical Programming Lead

Location: Mumbai, Bangalore, or Hyderabad, India

Job Function: Data Analytics & Computational Sciences, Biostatistics

Job Category: Senior Scientist, Biostatistics (ST6)

Job Description:

We are seeking a Clinical Programming Lead to join our Integrated Data Analytics & Reporting (IDAR) team at Janssen Pharmaceutical Companies of Johnson & Johnson. As a leader in the pharmaceutical industry, we are committed to creating a world without disease, and our Clinical Programming team plays a critical role in achieving this goal.

Responsibilities:

Provide expertise, hands-on delivery, and oversight of clinical programming activities, including SDTM submission-ready deliverables, back-end edit checks, listings, and tables
Integrate EDC, eSOURCE, and third-party vendor data into our internal Data Review Model (DRM) and CDISC SDTM submission-ready tabulation packages
Create and execute edit check programs and listings, and provide CRO oversight for outsourced trials
Develop efficiencies in clinical data flow using metadata-driven approaches and ensure consistency and quality across trials
Provide technical expertise and project-specific guidance to team members
Create and review internal DRM and SDTM mapping specifications, aCRF, datasets, define.xml, and cSDRG for stakeholder use
Manage interfaces and escalations with cross-functional project teams
Support and lead process, system, and tool improvement initiatives within compliance with departmental processes and procedures
Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL, etc.) and apply continuous learning as part of our next-generation data strategy (R, Python, Scala, Java, etc.)

Qualifications:

Bachelor's degree in Computer, Data, or Life Sciences or equivalent work experience is required; Master's degree preferred
6+ years of relevant experience in the pharmaceutical industry is desired; experience in other industries in a Programming role will also be considered
In-depth knowledge of protocol, current clinical drug development processes, and data structures and relevant programming languages for data manipulation and reporting
Advanced knowledge of SDTM, including Define.xml, CDASH, metadata, and experience transforming transferred vendor data into SDTM
Strong knowledge of complex finding data types, including biomarker, digital data such as ECG, imaging, etc.
Experience in planning and coordinating team activities, project management skills, and knowledge of team management principles
Demonstrated written and verbal communication skills
Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration

What We Offer:

A dynamic and diverse work environment
Opportunities for professional growth and development
A commitment to equal employment opportunity and a diverse and inclusive workplace

How to Apply:

If you are a motivated and experienced clinical programming professional looking to join a global leader in the pharmaceutical industry, please submit your application. We are committed to providing an accessible candidate experience, so please advise us of any accommodations needed to support you throughout the recruitment and selection process.

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Clinical Programming Lead

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