Principal Statistical Programmer
Multiple Positions Available
Location: South San Francisco
Responsible for all aspects of the statistical programming process from the extraction of clinical trial raw data through the finalization of project deliverables. Lead project level activities and perform data analysis primarily using the SAS programming language for the summary and interpretation of clinical trial data. Manage and create CDISC SDTM and ADaM files, SAS transport files and Define.xml used for electronic submission from the data received, in non-standard form, from various sources. Perform data analysis, statistical analysis, generates safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. Review data management plan, data validation plan and edit-check specifications. Contribute to the development of statistical analysis plans and implement the plans to all aspects of analysis programming including ADaM and TFL developments. Provide additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. Recognize inconsistencies and initiate resolution of data problems. Act as a liaison between statistical programming, subcommittees and project teams as needed. Work on significant and unique issues where analysis of situations or data requires evaluation of intangibles. Act independently to determine methods and procedures on new assignments. Work closely with biostatistics to create analysis files specifications following the instructions provided in statistical analysis plan (SAP). Develop SAS coding and output templates for preparing, processing and analyzing clinical data. Create and acquire tools to improve programming efficiency or quality. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
Bachelor's degree or foreign equivalent in Statistics, Public Administration, Engineering (any), or a related field plus eight (8) years of progressively responsible experience in the job offered or as a SAS Programmer, Statistical Analyst, Programmer Analyst, or a related position. Must have eight (8) years of progressively responsible experience within the pharmaceutical or biotechnology industry with: data management; SAS programming including SAS Base, SAS/Marcos, SAS/Graph, SAS/STAT, SAS/SQL, and SAS/ODS; CDISC standards, including SDTM and ADaM; integrated summaries (ISE/ISS); clinical study reports; ICH, FDA and GCP regulations and guidelines; clinical data management principles and systems; clinical trials process and regulatory requirements; oncology clinical trial data; survival analysis; web-based electronic data capture (EDC); and industry wide thesauri, including MedDRA. In the alternative, the employer will accept a Master's degree or foreign equivalent in a stated plus six (6) years of experience. Any suitable combination of education, training, or experience is acceptable.
Acerta Pharma invites applicants to apply by emailing resume to "firstname.lastname@example.org".
Must specify Job Code 4094297. EOE.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This document may be changed at management’s discretion.
Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.
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