Manager / Senior Manager Statistical Programming 9/16/2017
Iovance Biotherapeutics, Inc.
San Carlos, CA
JOB DESCRIPTIONAPPLY Overview
Reporting to the Director, Statistical Programming, The Manager/Senior Manager, Statistical Programming, will be responsible for hands-on statistical programming activities for clinical and non-clinical data. This includes, but is not limited to, programmatic generation and documentation of tabulation and analysis datasets (per the CDISC standard) and final deliverables (TFLs) to be included in regulatory filings, CSR, and publications.
Deliver accurate and reliable programming results, ensuring that validation policies and required documentation accompany all generated datasets and results.
QC validation of programming generated by vendor(s) and/or contractors to support final deliverables.
Build and maintain program directories with required documents to pass any future regulatory audits.
Provide high quality and accurate analysis outputs and supporting datasets that are delivered on time whether for production or validation programming.
Ensure all statistical programming activities are conducted in accordance with GCP, internal SOPs and meet all regulatory requirements.
Recommend technical solutions that can be used or developed to increase efficiency of project work, may assist Clinical Data Management for generating the database report and comprehensive review listings.
Debug and resolve issues related to other programmers' code during validation.
Develop efficient SAS macros and communicate issues with system macros to Director, Statistical Programming.
Develop, modify and complete specifications for both SDTM & ADaM datasets per the CDISC guidelines.
Review TFL mocks and provide appropriate feedback promptly. Add programming instructions to improve the mock document and reduce potential errors.
As applicable, provide oversight in the activities of internal and/or external SAS contractors.