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Portfolio Lead Clinical Programming (SDTM)

Location: UK
Company: Johnson & Johnson
Johnson & Johnson
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Clinical Programming: Portfolio Lead Clinical Programming (SDTM Programming) At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company. Within our Integrated Data Analytics & Reporting (IDAR) Clinical and Statistical Programming (C&SP) we are looking for individuals with the motivation to contribute to the growth of our Clinical Programming team to be located in High Wycombe UK, or Leiden, Netherlands; Beerse, Belgium; Basel, Switzerland; France; Italy Poland or Germany. This is an exciting opportunity to be part of a new innovative clinical programming group that is pivotal in defining our end to end automated data flow supporting next generation data strategies. The Portfolio Lead Clinical Programming (SDTM Programming) is accountable for providing expertise, hands on delivery and oversight of clinical programming activities integrating DC, eSOURCE, third party vendor data, mapping and transformation into CDISC SDTM submission-ready tabulation packages as well as CRO oversight for outsourced trials. This is a leadership position which will be responsible for a compound, disease or therapeutic area. Responsibilities include effective planning and execution of programming activities across multiple trials for assigned portfolio. This position drives operational excellence and consistent implementation of data standards. Strong analytical and problem-solving skills, technical insight and expertise within a given TA/disease area. This position may be responsible for the management and development of staff. Also responsible for contributing to our automation and innovation efforts. Responsibilities Include Create and review specifications for mapping internal data review model for safety and quality review as well as submission-ready CDISC SDTM. Edit check programming and ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); Ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive decision making, etc.) and compliant for database lock and submission-ready tabulation packages. Portfolio Lead responsibilities include planning, execution and completion of clinical programming activities. Understanding of portfolio demand and ensuring appropriate resources planned and available to support demand. Help drive operational excellence as a leader within the TA. Build and strengthen partnerships, community of practice as a leader within the therapeutic and assigned area of responsibility. May provide supervisory support to staff, including coaching, mentoring, training, career development, priority setting, etc. Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL, etc.) and apply continuous learning as part of next generation data strategy (R, Python, Scala, Java, etc.). Qualifications Qualifications Bachelors degree in Computer, Data or Life Sciences or equivalent work experience is required; Masters degree preferred Extensive relevant experience in pharmaceutical industry is desired, experience in other industries in Programming role will also be considered In-depth knowledge of protocol, current clinical drug development processes preferred Advanced knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS required. Expert knowledge of SDTM including Define.xml, CDASH, metadata preferred Experience in resource and standards compliance management preferred Knowledge of Data Management principles and tools, Clinical Data Management Systems and other clinical data sources preferred Team leadership and people development practices preferred. Ability to work with cross-functional team interpreting data requirements Strong project management skills and knowledge of team management principles are required Excellent written and verbal communication skills Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is preferred Vendor management oversight experience People management skills a plus Who We Are! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means You Belong! #GIFTS #CSPJOBSEU Primary Location United Kingdom-England-High Wycombe- Other Locations Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Switzerland-Basel-City, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Belgium Organization Janssen Cilag Ltd. (7360) Job Function R&D
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