Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must
- We believe in applying scientific rigor to reveal the full promise inherent in data.
- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- We prize innovation and seek intelligent solutions using leading-edge technology.
- Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
- Production and QC / validation programming
- Generating complex ad-hoc reports utilizing raw data
- Applying strong understanding/experience of Efficacy analysis
- Creating and reviewing submission documents and eCRTs
- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
- Performing lead duties when called upon
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
- Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
- At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
- Having experience/expertise working on Early Development studies. Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
- Develop and validate global programming standards for ADaM datasets.
- Develop and validate global programming standards for efficacy analysis, safety analysis and reporting.
- Design and develop complex programming algorithms.
- Experience in one or more of the following will be preferred: R, SPlus, NonMem.
- Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
- Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
- Up-versioning activities to specific versions of SDTM.
- Experience supporting Oncology studies would be a plus.
- Strong SAS data manipulation, analysis and reporting skills.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.
- Strong QC / validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Submissions experience utilizing define.xml and other submission documents.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Recommended Jobs
Receptionist - Seasonal
Job Description Job Description Why You’ll Love This Receptionist JobDid you ever want to work in aviation but didn’t know how to break into the industry? Would you like working in a fast-paced e…
Business Development Manager - National Accounts
Business Development Manager - National Accounts ~202600194 ~New York, United States ~Chicago, Illinois, United States ~Dallas, Texas, United States ~Boston, Massachusetts, United States …
Embedded Software Developer
Title: Embedded Software Developer Belong. Connect. Grow. with KBR! KBR's National Security Solutions team provides high-end engineering and advanced technology solutions to our customers i…
Office Manager and Housing Operations Coordinator
: At Wellesley, our mission is to deliver an outstanding liberal arts education to women who will make a difference in the world. Our collaborative community, comprising faculty, students, staff, and…
Development Test Engineer, Maritime
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business mode…
Cannabis Lab Manager
Actively Seeking New 21+ Pandas for our Cannabis Laboratory Manager position! Who Are We? Founded in 2014, Phat Panda is where innovation meets passion, and cannabis culture thrives. Our commitme…
barista - Store# 59964, NORTHAMPTON, KING ST.
Crafting the world's finest coffee, one meaningful moment at a time We believe in creating a warm and welcoming space where every cup of coffee sparks connection. Every shift is a chance to bri…
OB Laborist Physician
6-8 (24) hours shifts per month Our obstetricians are trained in the latest medical and surgical approaches, and provide our communities with the best practice of female reproduction and health car…
Project Delivery Senior Manager/Director
Careers at SolarKal offer the chance to work in sustainable energy, helping to promote a green, clean future. Help us accelerate the renewable energy revolution. Our driving purpose is to make …