Hello All,
Hope you’re doing well! Please go through the below job description & let me know your interest.
Title: SDTM Statistical Expert (Clinical SAS Programmer)
Location: Remote
Duration: 6 months
Abbvie is very specific; they want a resource who can provide a design specification for SDTM along with SAS programming skills.
To do extensive Python/SAS programming, writing and validating generalized macros, and to lead the team of Statistical Programmers (if required) involved in reporting and analysis of Phase I to Phase IV trials
To train the team members in developing strong analytical and programming skills using statistical software SAS or Python
ESSENTIAL QUALIFICATION:
· Graduate/Post-Graduate in Mathematics/ Statistics/Computer Science/Life Sciences
· Good programming and analytical skills using SAS software
· More than 5 years of experience as a SAS Programmer in Clinical Domain
ESSENTIAL SKILLS/PERSONALITY TRAITS:
· Sound knowledge of regulatory guidance documents such as ICH-E3 and ICH-E9
· Good knowledge and understanding of CDISC SDTM and ADaM standards
· Strong verbal and written communication skills
· Service excellence oriented with analytical and problem solving capabilities
· Planning and prioritization of work with concern of quality
· Initiative and setting the benchmarks for Team members
OPERATIONAL RESPONSIBILITY:
· Review DM documents like DTS, DVS, Visit matrix etc. to provide input to eCRF design.
· Review eCRF edit checks to setup database for data collection
· Review mock shell in accordance to TA, Project standards
· Create programming specification for SDTM & ADaM for both study and project according to Global standards.
· Create validation plan document for SDTM, ADaM and TFL’s
· Create and map the raw dataset to the SDTM standards
· Validate all the SDTM dataset according to the validation plan document as agreed
· Create and map the SDTM dataset to ADaM standards
· Validate all the ADaM dataset according to the validation plan document as agreed
· Develop Safety and Efficacy TFL’s according to the mock shells
· Validate all the Safety and Efficacy TFL’s according to validation plan
· Performing quality checks for all the reports generated by the team members and also do the validation of new/ modified SAS programs and macros
· To train the team on Protocol and SAP before starting the actual work on the study(as assigned)
· To train and assist other team members in Python/SAS programming as and when required
· Responsible for day-to-day work, process flows and constantly endeavoring to be able to set an example
· To assist the supervisor in providing the metrics on resource utilization, productivity and quality of deliverables
· To assist the supervisor in day to day activities such as providing the status on: deliverables, study updates such as timelines and any delay from client in providing the raw data/ SAP/ Protocol etc. and also discuss the challenges in meeting the timelines or quality of deliverables, if any
Regards…!!!!
Aravind
Sr. Recruiter | Talent Acquisition Team
Conquest Tech Solutions, Inc.
Phone: (302) 286-9010 EXT 111
Direct: 3024030874
Email: Aravind@conq-tech.com
20 C Trolley Square,
Wilmington, DE – 19806
