- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Apr 17 2020
Are you a highly motivated programmer, committed to quality delivery and development of data management studies and programs used to process data in clinical and epidemiological studies?? If so, GSK's Rockville Slaoui Center for Vaccines Research (SCVR) Programming Lead role could be an ideal opportunity to explore.
As a Programming Lead, you will develop and validate study and standard programs/macros (including SAS, PL/SQL. SPOTFIRE, R-Programming, Python) that support cleaning, monitoring, reporting and analysis of clinical trial data, as well as other requests from within or outside of Clinical-Data Management group.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
- Responsible for development and validation of CDASH and SDTM Mapping to support management of data at standards and studies.
- Responsible for the development of aCRF, SDRG, Pinnacle 21 annotation and definexml for various standard or specific studies.
- Trouble shooting and debugging of complex standard and study programs/macros.
- Establish and maintain effective working relationships with other programmers and business users to understand the requirements and related data.
- Requirement gathering, development of specifications, Validation plans and performing end to end validation of Standard/Study macros.
- Understand and provide technical support for various clinical oracle tables and their interactions with different interfaces and standard/study macros in GSK environment.
- Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.
- Ensure that programs and macros are consistent and comply with company and industry standards and best practices. Ensure quality control and quality audit of deliverables.
- Act as subject matter experts for tools, programs, macros in scope of CDISC CoE & Programming group.
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree
- Minimum 1-2 years' experience in clinical research or clinical data management
- Proven experience of working with SAS Software and PL/SQL
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations including ICH-GCP
- Ability to apply knowledge to understand complex SAS macros, SQLs, Databases, processes, interfaces and systems in the pharmaceutical industry.
- Strong knowledge / experience in IT tools, statistical software. and validation methodology
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Master's degree preferred
- Excellent programming skills in SAS is required, skills with other relevant tools is desired
- Knowledge of CDISC Standards CDASH & SDTM, ADaM knowledge as a plus
Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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