Job Description
JOB DESCRIPTION:
We are seeking an experienced Statistical Programmer to support clinical trial analysis and reporting in the Global Clinical Affairs organization. The role includes statistical programming support for clinical study reports and publications, and validation of statistical programs. This role will work with statisticians, statistical programmers, and clinical study teams on clinical studies in a variety of therapy areas.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
• Provides statistical programing support for assigned clinical studies or projects
• Creates analysis datasets per specifications for each study
• Programs customized data displays in accordance with approved statistical analysis plan and shell displays for clinical studies
• Reviews table shells for clinical study reports
• Writes statistical programs to generate tables, figures and listings for clinical study reports
• Prepares documentation for statistical programs
• Conducts data checks to ensure data integrity
• Creates standard macros to improve efficiencies
• Provides input on standardization of processes, programs and documentation to improve efficiencies
• Conducts validation activities as assigned
• Maintains current knowledge in developments in statistical programming languages (SAS)
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
Your required experience(s), education and knowledge will further expand Abbott's marketplace success:
Under the supervision of a statistician, this role will support accurate and timely reports to regulatory authorities, analyses to support publications activities.
Qualification
M.S. degree in statistics, biostatistics or related majors with 3 years minimum experience (PhD in statistics/biostatistics or related majors with 1 year experience) in statistical or SAS programming reqiured; 2 year experience in medical device or pharmaceutical clinical research studies prefered. Bachelor's degree with 5 or more years experience will be considered as well.
Familiarity with at least one statistical programming package required; extensive experience with SAS preferred. Knowledge of at least one database software package required. Experience working on medical device clinical studies in highly regulated environment preferred.
Able to work both independently and as a team member. Experience coordination, prioritizing and setting timelines for multiple tasks. Good organizational and time management skills. Able to communicate effectively, both orally and in writing. Able to describe complex procedures concisely and accurately. Excellent attention to detail and accuracy
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
MD Medical Devices
LOCATION:
United States > Santa Clara : Building A - SC
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Date Posted
09/05/2022
Views
6
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