SCHARP Career Opportunities

EDC Programmer I/II

Vaccine and Infectious Disease Division
Category: Information Technology
Seattle, WA, US
Job ID: 24392

Overview

 

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

 

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.



The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking an Electronic Data Capture (EDC) Programmer leve I-II.

 

The EDC Programmer supports the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) clinical data management team. The EDC Programmer works with the study team to configure and program data entry screens, edit checks, custom functions, custom reports, data integrations, test plans and user/site accounts for clinical study builds in EDC clinical data management systems in support of clinical trials run by SCHARP and its partners. This position also plays a key role in providing technical support for the EDC Medidata system functionality including, but not limited to reporting, data inputs/outputs, randomization, laboratory administration, targeted source data verification, and safety gateway among other modules. In addition, this role performs quality check activities on configuration and programming collaborating with fellow EDC Programming team members.

 

Responsibilities

 

  • Database design specification in consultation with Data Management, Lab Data Management, Clinical and Statistical Programming, Data Analytics, Clinical Coding, and Safety.
  • Independently configure and program clinical trial forms, visit schedules, edit checks and other study requirements in EDC systems using applied knowledge or programming and data standards.
  • Collaborate on/update global library as appropriate according to best practices and new standards.
  • Validates specification to development through leading team review, co-programmer review, and User Acceptance Testing.
  • Verifies completeness of study deliverables prior to release.
  • Performs verification of quality and completeness of study deliverables prior to release.
  • Performs peer review for configuration and programming completed by other EDC programmers for both new study builds and post-production changes.
  • Support clinical programming requests from study teams as assigned, applying knowledge of EDC tools and data standards to complete requests in the timelines defined.
  • Perform EDC Operational Support for EDC systems and modules including but not limited to: Medidata (Rave, Balance, Business Objects 4, PDF Generator, iMedidata, Translations Workbench, Reporting) and Forte EDC.
  • Perform user and site administration to include site set up and assignment of roles, permissions and training/elearning requirements.
  • Supports other activities as assigned.

Qualifications

 

Minimum Qualifications

  • EDC Programmer I - Bachelor’s Degree in Computer Science, Information Technology, Life Sciences, a related technical field, a foreign degree equivalent, or Equivalent experience, AND at least 2 years’ experience configuring/programming a clinical trial EDC system.
  • EDC Programmer II - Bachelor’s Degree in Computer Science, Information Technology, Life Sciences, a related technical field, a foreign degree equivalent, AND 3+ years’ experience configuring/programming a clinical trial EDC system OR equivalent combination of education/experience will substitute for minimum qualifications.
  • Fundamental understanding of clinical trials, EDC systems, and Data Management.
  • Demonstrated programming skills (C#, SQL, or similar programming experience highly desirable).
  • Excellent written & oral communication skills including grammatical/ technical writing skills.
  • Working knowledge of Microsoft Word, Excel and PowerPoint.
  • Effective time management and organizational skills.
  • Must work well independently and be self-motivated.
  • Candidates should be detail-oriented with strong analytical and critical thinking skills.

Preferred Qualifications

  • Master’s degree in computer science/information technology or life sciences.
  • Experience with development, validation, and execution for regulatory submission.
  • Expertise with reporting tools; Business Objects, J-Review, and/or Spotfire.
  • Applied knowledge of CDISC/CDASH/SDTM.
  • Experience with external data handling of study data.
  • Experience with clinical dictionaries; MedDRA and WHO dictionaries.

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.


The annual base salary range for the I level is from $70,817 to $106,225 and pay offered will be based on experience and qualifications.   

The annual base salary range for the II level is from $86,078 to $129,118 and pay offered will be based on experience and qualifications.   

 

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).  

Statistical Programmer II/III (Salaried)

Vaccine and Infectious Disease Division
Category: Biostatistics, Bioinformatics and Computational Biology
Seattle, WA, US
Job ID: 24394

Overview

 

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

 

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.



The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research and COVID-19 vaccine development. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Programmer Level II-III to provide statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, re-suable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses SAS with experience using R a benefit; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect.

Responsibilities

 

  • Gather and document requirements for developing or modifying existing programs and systems
  • Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
  • Generate, document, and maintain analysis datasets
  • Develop scripts for wrangling / data transformation and standardizing assay datasets
  • Create ad hoc, standard and study-specific reports (e.g. SMC, DSMB, SMB, Assay QC); may perform cross- study reporting
  • Test and de-bug programs and maintain version control on production programs and scripts
  • Design and develop new work instructions (WIs) and updates to existing WIs.
  • May coordinate efforts to standardize WIs or processes across studies
  • Develop and maintain automation of routine analysis data and reporting tasks
  • Contribute to good programming practices, and cross-group programming initiatives and code libraries
  • Work with clinical programmers, labs, statisticians, and other statistical programmers to resolve data quality, processing, and analysis issues
  • May contribute to mentoring and training of junior Statistical Programmers and may supervise as needed

Qualifications

 

MINIMUM QUALIFICATIONS

  • Bachelor’s degree in Computer Science or a scientific, technical, or health-related field
    • Level II: Two years of experience as SAS or R programmer on PC/Unix platform; Preferred experience programming in support of clinical trials, statistical programming in a clinical research setting or other health research programming support; R programmers will have experience using version control tools (e.g. git or svn)
    • Level III: At least four years of experience as SAS or R programmer on PC/Unix platform; Preferred experience programming in support of clinical trials, statistical programming in a clinical research setting or other health research programming support; R programmers will have experience using version control tools (e.g. git or svn)
  • Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
  • Demonstrated ability to multi-task and appropriately prioritize work assignments
  • Knowledge of and experience with clinical trials research data or experience in data wrangling /transformation within a health-related field
  • Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting
  • Strong reporting and SAS macro or R package development abilities


Additional Minimum requirement for Level III

  • Advanced SAS or R programming skills
  • Knowledge of SAS or R (including graphics experience) and other programming languages
  • Ability to use Perl or other scripting languages for text manipulation and automated job control


PREFERRED QUALIFICATIONS

  • Graduate degree in computer science or a scientific, technical, or health-related field
  • Knowledge of CDISC standards (SDTM and ADaM)
  • Experience using version control tools
  • Knowledge of laboratory and biological assay data

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.


The annual base salary range for the II level position is from $79,594 to $119,392 and pay offered will be based on experience and qualifications.   

The annual base salary range for the III level position is from $91,936 to $145,318 and pay offered will be based on experience and qualifications.   

 

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).  

 

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