Job-ID31754439Reference26-00105 Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements Provides input in the design and development of case report forms and clinical databases Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs Programs quality checks for clinical study raw data and report the findings to Data Management Provides input in the design and development of case report forms and clinical study databases Reviews or author eCRF, SDTM and ADaM datasets specifications for datasets programming Provides programming support for adhoc analysis Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications) Manages timelines and schedules of specific phases of projects with internal personnel and external vendors Acts as lead programmer for a study Reviews or validates statistical deliverables of vendors for assigned project(s) Requirements: MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years. Experience in providing statistical programming support to early and late phase clinical trials. Excellent skills in SAS programming and statistical reporting. Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements. Familiarity with FDA and ICH regulations and guidelines. Excellent problem-solving skills. Good written and verbal communication skills and organizational and documentation skills. Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc. Ability to prioritize and multi-task effectively Demonstrated positive attitude and the ability to work well with others.
...Job Description Job Description $500 Paid CDL Training Program! Now hiring school bus drivers for employment during the school year in Howard County. Bus drivers earn $28.00 - $32.65 per hour Every employee is guaranteed a 6-hour-minimum work day, are...
...Commercial Roofer We are growing and looking for the best of the best roofing professionals! Are you looking for year round work and growth opportunity? If the answer is yes, then we want to meet with you!! Skills/Qualifications needed: Commercial roofing...
...monthDiscounts on productsQualified Candidates: Satisfies all licensing requirements to perform services in [STATE/COUNTY/CITY]Have a... ...their skin care goalsCulture & Support: Award programs (like Esthetician of the Year)Trained leadership that is invested in YOUR...
...Coordinate and delegate crew work assignments and to relieve Master/Mate who is on watch. ESSENTIAL DUTIES/FUNCTIONS: Coordinate... ...: Shall have sufficient mathematical ability to determine ship's position, speed, and ETA. Shall be attentive to details and alert...
...Weekday work is flexible - weekends are REQUIRED. Internship is unpaid however you will gain a wealth of knowledge about youth sports operations and marketing. Do you love... ...in the Salt Lake Metro area Assist in managing game day operations, the on-field customer experience...