Associate Director, Statistical Programming

South San Francisco
Clinical – Biometrics
Full Time
NGM Biopharmaceuticals, Inc. is a clinical stage biotech company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases.  Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to form a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine.  To date, NGM Bio has generated a pipeline of six drug candidates in various stages of development targeting liver, metabolic, ophthalmic, and oncologic diseases. The most advanced drug candidate, NGM282, is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH).  NGM’s strategic collaboration with Merck, which was extended to March 2022, will continue to provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates. 

The Associate Director, Statistical Programming (SP) will manage/oversee all SP activities in support of NGM clinical development programs. The person in this position will work closely with internal Biometrics teams and external vendors to ensure the quality and compliance of all SP deliverables while adhering to study/project timelines.

Responsibilities

    • Represent SP in meetings with internal teams and external vendors, collaborate with cross-functional individuals in support of study/project deliverables.
    • Provide SP support for the development and validation of programs that generate tables, listings and graphs for clinical study reports and submission-ready CDISC (SDTM and ADaM) data packages.
    • Collaborate with Biostatistics, Clinical Data Management, and other development functions over the course of trials, provide SP support for database development and ensure the data quality, integrity and compliance with applicable regulatory requirements, and address ongoing team needs for programming support.
    • Provide SP oversight of the vendors, define/develop and implement procedures, guidelines and policies for good programming practices, and perform quality control of SP deliverables.
    • Provide SP support for decision making, regulatory submissions, and medical affairs/publications, etc.

Education, Experience, and Skills

    • BS or MS (preferred) in Statistics/Biostatistics, Mathematics, Computer Science or related fields, at least 12 (10 years for MS) years of statistical/clinical programming experience in biotech or pharmaceutical industry
    • Comprehensive understanding of statistical/clinical programming processes and standards in clinical drug development
    • Broad experiences with statistical programming using SAS including development and use of SAS macros
    • Extensive experience with CDISC standards (CDASH, SDTM, ADaM)
    • Experience managing FTEs, consultants and CROs
    • Experience with NDA/BLA submissions highly desirable
    • Effective communication skills, strong collaborative and interpersonal skills 
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.

Interested applicants should apply through the NGM Biopharmaceuticals website: https://www.ngmbio.com/open-positions/