Job Description
The Data Transformation and Submission (DTS) group within our Biostatistics & Programming department performs active global CDISC submission development for clients in our Biotech, Biopharma and FSP groups. There is also responsibility for Spotfire exploration, SDTM, DSUR reporting, eCRT (Define.xml) as well as cross functional development initiatives with various internal departments, including CDM, Early Dev Services, PVG, etc. The DTS group also works on many stand-alone studies that are led and driven fully within the group.
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As a Principal Programmer within DTS, you will perform specification, development, quality validation and regulatory submission compliance for PPD's CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables, using Windows SAS Grid. You will deploy Spotfire dashboards, Safety notifications and reporting for Medical Monitor review and regulatory actions. As a DTS team member, you will be a key team player for internal Biostatistics interactions and client engagement on CDISC submission topics, or internal contact for procedural and technical solutions.
Your responsibilities will include (but are not limited to):
- Act as programming lead on Phase II-IV group of studies.
- As programming lead assume leadership responsibility as a contributing member of a global project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
- Provides input into bidding process as requested.
- May provide general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials etc.
- Provides training, guidance, and project leadership to junior team members.
- Develop instructional training and education materials for the wider B&P community.
- Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF).
- Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
- Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
- Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.
Education and Experience:
- Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 6 years of experience.
- Advanced SAS programming skills and understanding of database structures.
- Capable of facilitating communication with clients, project teams, departments and staff.
- Solid decision making skills to decide company policies and procedures regarding programming.
- Solid understanding of tracking project budgets.
- Understand and participate in bidding programming work.
- Demonstrated leadership, motivation and problem solving capability.
- Good understanding of clinical trials.
- Capable of effectively organizing and managing multiple staff and assignments.
- Proficiency in at least one programming language and strong technical programming skills.
At PPD clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.
We have a flexible working culture, where we truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!
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