Principal I Portfolio Lead Clinical Programming HyderabadBangaloreMumbai

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Job Description:

Principal I Clinical Programming Lead (SDTM Programming)

Position Summary:
The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programminglanguages tools and complex data structures industry standards. The position requires proventechnical and analytic abilities and strong capabilities in leading activities and programming teams inaccordance with departmental processes and procedures.
As a highly experienced Principal Programming Lead they apply expert technical scientific problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency acrossassigned projects providing training coaching mentoring to other programmers.

The Principal Programming Lead position is accountable for the planning oversight and delivery ofprogramming activities in support of one or more clinical projects compounds or submissions of highcomplexity and criticality.

In this role the Principal Programming Lead is responsible for making decisions and recommendationsthat impact the efficiency timeliness and quality of deliverables with a high degree of autonomy andprovide leadership direction and technical and project specific guidance to programming addition this position may lead and contribute expert knowledge and technical skills to assigneddelivery unit departmental innovation and process improvement projects.

Principal Responsibilities:
Designs and develops efficient programs and technical solutions in support of highly complex/criticalclinical research analysis and reporting activities including urgent/on-demand analysis requests.
Provides technical and project specific guidance to programming team members to ensure highquality and on-time deliverables in compliance with departmental processes.
Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching toprogrammers in developing advanced technical and analytical abilities.
Performs comprehensive review of and provides input into project requirements and
documentation.
Collaborates effectively with programming and cross-functional team members and counterparts toachieve project goals and independently manages escalations.
As applicable oversees programming activities outsourced to third party vendors adoptingappropriate processes and best practices to ensure their performance meets the agreed upon
scope timelines and quality.
Responsible for adoption of new processes & technology on assigned projects/programs incollaboration with departmental technical groups and programming portfolio leads

Oversees the design development validation management and maintenance of clinical databasesaccording to established standards.
Responsible for implementation of data tabulation standards.
Performs data cleaning by programming edit checks and data review listings and Data reporting bycreating data visualizations and listings for medical monitoring and central monitoring.

Education and Experience Requirements:
Bachelors degree (e.g. BS BA) or equivalent professional experience is required preferably inComputer Sciences Mathematics Data Science/Engineering Public Health or another relevant scientificfield (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g. Master PhD).

Experience and Skills Required:
Approx. 10 -12 years of experience in Pharmaceutical CRO or Biotech industry or related field orindustry. People management experience is mandate.
In-depth knowledge of programming practices (including tools and processes).
Working knowledge of relevant regulatory guidelines (e.g. ICH-GCP 21 CFR Part 11).
Project risk and team management and an established track record leading teams to successfuloutcomes.
Excellent planning and coordination of project delivery.
Established track record collaborating with multi-functional teams in a matrix environment andpartnering with/managing stakeholders customers and vendors.

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Preferred Skills: