Location: 121 Oyster Point Blvd., South San Francisco, CA 94080
Provide technical and scientific expertise to enable optimal study design, analysis, and reporting. Develop processes and standards that are in accordance with GCP and ICH guidelines. Serve as primary liaison for statistical issues and programming specifications between biometrics and other functions, including clinical development, medical safety, clinical operation, pharmacology, translational science, and patient report outcomes. Oversee biostatistical contractors as required. Choose appropriate study design and statistical methodology, defining endpoints, calculating necessary sample sizes, and writing statistical sections of the protocol. Develop statistical analysis plans. Support analysis activities for clinical and regulatory documents, including Clinical Study Report (“CSR”), Investigator Brochures (“IB”), Development Safety Update Report (“DSUR”), Periodic Benefit-Risk Evaluation Report (“PEBER”), Integrated Summary of Safety (“ISS”) and Integrated Summary of Efficacy (“ISE”). Establish and negotiate accurate timelines with internal and external team members for completion of study-related biostatistical activities. Generate, review, and approve tables, listings, and graphs in collaboration with statistical programmers to ensure accurate and appropriate analyses and results. Conduct validation and quality control of product deliverables. Apply statistical methods to clinical trial data, including survival analysis. Work on Oncology clinical trials. Use SAS, including DATA step, SAS macros, SAS/STAT, SAS SQL, SAS GRAPH and ODS output. Work on clinical trials with Immunotherapy (I-O). Support randomized phase 2 clinical trial. Perform data manipulations, analysis, and report analysis results from SDTM and ADaM datasets for interim analysis and final analyses. Responsible for production of data visualization for safety and efficacy data. Program QC efficacy and safety outputs. Must utilize knowledge of CDISC standards, ICH and FDA guidelines.
Master’s degree or foreign equivalent in Statistics, Biostatistics, Epidemiology, Biotechnology, or a related field plus three (3) years of experience in the job offered or as a Biostatistician; Clinical Data Scientist; or a related position. Must have at least three (3) years of experience within the biotechnology or pharmaceutical industry with: Applying statistical methods to clinical trial data, including survival analysis; Working on Oncology clinical trials; SAS, including DATA step, SAS macros, SAS/STAT, SAS SQL, SAS GRAPH and ODS output; Clinical trials with Immunotherapy (I-O); Randomized phase 2 clinical trial; Data manipulations, analysis, and reporting of analysis results from SDTM and ADaM datasets for interim analysis and final analyses; Production of data visualization for safety and efficacy data; Programming QC efficacy and safety outputs; and CDISC Standards, ICH and FDA guidelines. 15% national and international travel is required to various and unanticipated company and client sites.
Full Time: Mon - Fri (40 hrs/week)
Acerta Pharma invites applicants to apply by emailing resume to "email@example.com". Must specify Job Code 4144897. 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.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
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