Plan, assign and oversee all the statistical programming activities clinical trials / studies and manage resources; Build datasets from clinical database to perform statistical analysis and data visualization of biological data; Revise and develop standard operating procedures to ensure compliance with Good Clinical Practices; Provide expertise in development and quality control process for scientific programming; Develop processes for process improvement and automation; Create and maintain programming specification documents; Perform edit checks and assist review edit specifications; Utilize SDTM / ADaM guidelines to prepare SAS programs for standardized clinical datasets; Validate the programmed analysis clinical datasets, tables, listing and figures; Represent department in internal cross-functional project team meetings and audits; Participate in department and cross functional technology development and process improvement initiatives; Assist in compiling technical documents for internal and external audits; Work in tandem with Biostatistics and Data Management members on various clinical projects; and Provide training and assistance to junior members of the Scientific Programming group.
Location : 20201 Century Blvd, Suite 450, Germantown, Maryland 20874
Education : Bachelor's - Bioinformatics, Pharmaceutical Science or a related field of study; Will accept equivalent of foreign degree.
Experience : None.
Education and / or Experience must include :
Instrumental Methods of Analysis;
Research Methodology and Statistical Methods;
Chromatographic Methods of Analysis; and
Biological Methods of Screening
Sheri Threadgill
Principal Human Resources Business Partner
Amarex Clinical Research, LLC.
20201 Century Blvd., Ste. 450
Germantown, Maryland 20874
Attn : LC25-101
Scientific Director • Germantown, MD, United States