Associate Director, Statistical Programming

Biometrics (610) · Berkeley, California
Department Biometrics (610)
Employment Type Full-Time
Minimum Experience Experienced

Company:


Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

 

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.

 

Position:

 

The Associate Director, Statistical Programming will be responsible for the planning, implementation, and compliance of clinical trial statistical programming activities across multiple studies to produce high quality and timely deliverables for global submissions.  In addition to overseeing internal statistical programming activities, the role will provide oversight of external business partners, including technology vendors and CROs, and management of external electronic data sources in order to support drug development processes and global submissions.  The Associate Director of Statistical Programming will be based in the Seattle, Washington office and will report to the Head of Biometrics or Head of Statistical Programming.  

 

 

 Responsibilities include:

  • Serve as Lead Statistical Programmer on multiple complex projects or products in the Statistical Programming function, including NDA/BLA and other submissions to regulatory agencies
  • Lead Statistical Programming activities for successful implementation of data transformation (SDTM, AdAM, raw non-EDC) to support data visualizations and regulatory submissions
  • Lead, manage, coach, develop, and support Statistical Programmers within the Biometrics Department
  • Ensure the quality of Statistical Programming deliverables, including oversight of CRO biostatistics deliverables
  • Author functional documents or provide input to key study-related documents produced by other groups (e.g. Protocol, SAP, CRFs, TFL shells, etc.)
  • Collaborate with stake holders and cross functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development to standardize, maintain and implement the data transformation and data visualization requirements
  • Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit
  • Perform/assess time and resource estimates for project planning, manage timelines for studies/projects, and oversee contracts and budgets for CROs
  • Produce timely, high quality, and reliable clinical trial data for internal decision making, regulatory approval and market acceptance
  • Develop SOPs to support Statistical Programming and biometrics activities including work instructions, program validation, and documentation
  • Participate in Clinical Project Teams and support regulatory submission activities
  • Contribute to the development and maintenance of a positive team-focused company culture

 

Education, Experience, and Skills:

  • Bachelor’s degree or higher
  • Minimum of 10 years experience in leading and supporting statistical programming activities in clinical research for all phases of clinical trials, supporting global trials.
  • Knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other guidance documents and policies related to clinical trials and operations requirements
  • Extensive knowledge of and experience with CDISC standards including SDTM and AdAM dataset specifications and Define-XML
  • Understanding of SAS programming concepts and techniques in the pharmaceutical industry and ability to correct limitations in strategy proactively
  • Ability to manage multiple complex projects and assess resource needs
  • Excellent SAS Programming skills, with a thorough understanding of clinical data structures, and the ability and willingness to work hands on for study level programming support
  • Ability to analyze information, review reports, communicate outcomes, and prioritize actions
  • Excellent computer skills; strong verbal and written communication skills 
  • Ability to work well in a team environment both as a contributor and leader
  • Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships

 

 Chinook is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

 

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  • Location
    Berkeley, California
  • Department
    Biometrics (610)
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced