Job Description

JOB DESCRIPTION As a Programmer Analyst within DTS, you will perform specification, development, quality validation and regulatory submission compliance for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables, using Window

JOB DESCRIPTION As a Programmer Analyst within DTS, you will perform specification, development, quality validation and regulatory submission compliance for PPD developed 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. We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our Biostatistics & Programming (B&P) department are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry leading CDISC expertise and programming leadership through global delivery, consistent quality adherence and scientific insight. Your responsibilities will include (but are not limited to) the following: 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. Act as programming lead on Phase II-IV studies of simple to moderate complexity. As programming lead working directly with project team leaders and client representatives and where required to conduct team meetings, develop, and maintain project timelines, assess, and forecast resources, and monitor study budgets. Provide mentorship to junior team members. Job Qualification Master's Degree inComputer Science,Biostatistics, Statistics, Mathematics, or related field. 3+ yearsof experience working in Biostatistics (previous CRO experience ishighlydesirable). SolidSAS programming experience- Minimum 1-2 years. Understanding of one or more additional programming languages is a plus. Strong understanding of relational data base structure and complex data systems. Project managementor leadexperienceis desirable. Capable of providing mentorship and promotingteamworkin a multi-disciplinary team setting. Fluency in English is essential. At PPD we hire the best, develop ourselves and each other, andrecognisethe power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and developmentprogramme, 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 haveaflexible working culture, where PPD truly value a work-lifebalance.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 aglobalorganisationbut with a local feel. -We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD- If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application- we'd love to hear from you. Diversity Statement PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status, or status within any other protected group.