Senior Statistical Programmer - Newark - job 854067

Protagonist Therapeutics

Date: 06/11/2021

City: Newark, California

Employment type: Full-time

Job Summary:


Senior Statistical Programmer will perform statistical analysis using statistical software (SAS, R, etc.) on clinical data in a research and development environment. Person in this position will create standard study datasets (ie SDTM), analysis datasets (ie ADaM), and data definition specifications (i.e. Define-XML); assess quality of data analysis programs; develop automated analysis tools where appropriate; create and maintain listings, tabulations, and graphical summaries; and conduct formal statistical estimates and tests. This role will also be responsible for developing programs to assist with data review such as edit checks and custom listings, for performing data integration used in clinical summaries and for creating and doing quality control of statistical submission components to regulatory agencies. Person in this position will collaborate with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.


Position Requirements:



  • Independently develop SAS or other programs, and specifications (eg SDTM, ADaM), for use in study or other analyses, eg, Integrated Safety Summaries.

  • Must be able to check results, and consistently produce accurate output and independently verify other programmer's results.

  • Produce data definition documents (ie Define-XML), including reviewer's guides and SDTM annotated CRFs.

  • Serve as oversight, point-of-contact, and quality control for datasets in SDTM and ADaM format as well as tables, listings, and figures (TLFs) produced by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.

  • Follow regulations and company policies regarding training records, guidelines, and SOPs.

  • Support ad-hoc requests as needed.

  • Work on multiple tasks at the same time and prioritize tasks to meet business needs.

  • Trouble-shoot technical and project issues.

  • Help with the infrastructure development of the department.

  • Assist team to ensure timelines for the study and/or project are met.

  • Assist with training new employees and contractors, in particular on study specifics and departmental programming conventions and standards.

  • Meet timelines on a regular basis.


Education:



  • BS/BA degree in related discipline with 8 years of related experience; or

  • MS/MA degree in related discipline with 5 years of related experience; or

  • PhD in related discipline and one year of related experience


Skills:



  • At least 5 years' experience in statistical programming in Biotech/Pharmaceutical industry with clinical data and SAS

  • Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS Macros

  • Knowledge of CDISC


Protagonist Therapeutics is a clinical stage biopharmaceutical company with multiple peptide-based new chemical entities in different stages of development. PTG-300 is an injectable hepcidin mimetic in a Phase 2 proof-of-concept clinical trial for polycythemia vera, and a separate Phase 2 clinical study for hereditary hemochromatosis. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in a Phase 2 clinical trial for Crohn's disease. Two additional oral peptide interleukin-23 receptor antagonist candidates are in development: PN-235, in a Phase 1 study, and PN-232, in the late preclinical stage. PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in a Phase 2 study for the potential treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication. The Company utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms.





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