Senior Clinical Programmer (12-month TERM)

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

 

12-month TERM 

TERM employee' means a project-specific employee holding a position for the time period specified above [OR: for 12 months], with a projected discharge date which may be adjusted according to funding limitations or completion of work. Employees hired to fill a TERM position enjoy all the benefits of a regular employee, including 401k, healthcare coverage, and ESPP, with the exception of equity grants and employment protection beyond the life of the designated project(s).  

 

The Opportunity

In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Sr. Clinical Programmer. The Sr. Clinical Programmer will work with the Clinical Data Management team to support the data management activities, will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner, and will provide support to cross-functional teams as needed. This individual will also independently perform tasks related to data listings outputs and report setup, QC checks to support the processing and cleaning of clinical trial data, following all applicable standard and study-specific procedures.

 

Responsibilities

• Utilizes primary development tools including SAS, R and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation in support of import setup and processing, export setup and processing, listings, and custom reports.
• Manages internal and external data transfer processes and reconciles data from multiple sources to facilitate reporting outputs as defined in the Clinical Data Management (CDM) documents.
• Serves on study/project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and shares constructive feedback.
• Provides application administration and technical support on core business packages including but not limited to: SAS, R and Medidata Rave.
• Provides technological support to the Clinical Programming staff, Data Managers, etc
• Ensures high quality deliverables by providing peer review of study level/program level outputs for accuracy.
• Leads Clinical Programming activities on two (2) or more concurrent studies depending upon scope, similarity, program, and resourcing requirements.
• Reviews and writes process documentation (SOPs and Wis) as needed.
• Contributes to the development of Clinical Data Management (CDM) documents, including the Data Management Plan (DMP), output specifications and data transfer processes.
• Offers input into initiatives and new technologies/innovations to improve CDM processes; represents Clinical Programming through working groups and initiatives.

Qualifications

• Bachelor’s degree preferred, or equivalent combination of related education and experience.
• Minimum of 3 years of relevant experience as a SAS or R programmer in drug research and development
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Demonstrated experience in managing multiple priorities in a highly dynamic environment
• Experience and knowledge in the application of data standards.
• Familiarity with data capture systems and databases (i.e., Medidata, Rave, Oracle OC/RDC,Oracle Inform)
• Knowledge and understanding of clinical data flow, transfer, and integration
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
• Preferred: Working knowledge of clinical data repositories
• Preferred: Experience in working with visualization packages (i.e., Spotfire, Tableau)

 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment.  We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $130,000 to $160,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive