Responsibilities:
To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies and publications.
Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, and other internal and external requests (e.g., publications).
Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).
Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
Working closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management.
Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
Maintaining standards for programming activities.
Working independently to accomplish tasks and goals defined by supervisor.
Bringing in new ideas to improve the programming process.
Requirements:
Minimum of bachelor's degree in related science discipline.
Minimum 7+ years' experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
Experience in CDISC data standards, e.g SDTM and ADaM.
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve issues.
Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment.
...Job Description Job Description In conjuncion with Talent Model Recruiters, we are seeking new and experienced models for the apparel and fashion industry to display clothing and merchandise in commercials, advertisements, and/or fashion shows. Promote products and...
...5 Positions Period of Employment: 1 Year Contracts renewal every year. Working Hours: 40 hours per week / based on schedule / (Permanent night shift) Work Station: Work from home Job Requirement: Excellent English and Fluent in their respective native...
Job Summary: Detail-oriented Web Developer / Web Accessibility Specialist responsible for auditing... ...compliance with ADA Title II, WCAG Level AA, and Section 508 standards. This role... ...to work onsite three days per week with remote work for two days. Scheduling:...
...Assist the School Leader in improving the quality of instruction at the Academy at an aggregate level as well as at the classroom and student... ...best benefit the individual classroom teacher. . Employ coaching processes that foster increased autonomy in direction and...
Halff in Austin, TX is seeking an Intern for our Landscape Architecture team. You will collaborate with an interdisciplinary team of landscape architects, planners, and others to support a wide range of public and private landscape projects, including park design, trails...