SCHARP Career Opportunities

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. 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 Biostatistician III or IV.

The Biostatistician provides high intermediate-level (III) or low advanced-level (IV) statistical support in the planning, operations, monitoring, analytic, and exploratory stages of clinical trials and research.

Responsibilities

May include some or all of the following:

• Collaborate with PhD statisticians/epidemiologists, Statistical Research Associates (SRAs), laboratory scientists, laboratory data managers, and other subject-matter experts to provide statistical support for clinical studies and research projects or laboratory data and analyses including statistical considerations and planning (power and sample size calculations), randomization lists, consultation, study data analyses, and written summaries and tables of results for use in study reports - for example, Data and Safety Monitoring Boards or other interim review meetings, scientific abstracts and manuscripts, and/or tables in support of a Clinical Study Report for submission.
• Contribute to and review study documents including protocol drafts, statistical analysis plans, case report forms, and other documents as required.
• Collaborate with data management and operations in the development of quality assurance procedures for on-going data collection, cleaning and analysis - such as establishing edit checks, or HIV endpoint verification.
• Participate in and lead verification of standard reports prepared by programmers or other team members.
• Apply and adhere to CDISC data standards and guidelines where required in the production of analysis datasets and reports; assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides).
• Generate written summaries for use in customized statistical lab reports.
• Participate in and lead when appropriate protocol team conference calls and meetings, organizational meetings, interim data review meetings, scientific meetings, regional meetings and internal team meetings as required.
• Maintain functional understanding of standard policies and procedures and complete required training in a timely manner; Contribute to the development and maintenance of standard procedures and related quality documents.
• Participate in and lead internal project initiatives which may include developing new tools and processes, evaluating new statistical software packages, or exploring other value-added team activities.
• Represent SCHARP and the data analytics unit at professional meetings.
  Mentor or formally supervise more junior SRAs as required. Conduct performance reviews of direct reports.
  Perform other responsibilities as required.

Qualifications

Minimum Qualifications

Biostatistician III:

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience.
• A minimum of 3 years of related work experience is required.
• Proficiency with the SAS or R (as required by specific team/project).
• Demonstrated knowledge of general statistical practice within clinical trials.
• Thorough understanding of statistical programming process and best practices.
• Functional understanding of GCP and regulatory requirements.
• Proven track record of collaboration with internal colleagues.
• Strong oral and written communication skills.

Biostatistician IV:

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience.
• A minimum of 4 years of related work experience is required.
• High-level proficiency with the SAS or R (as required by specific team/project).
• Demonstrated functional knowledge of general statistical practice within clinical trials.
• Thorough understanding of statistical programming process and best practices.
• Minimum of 1 year of experience in a senior, lead or management role.
• Minimum of 1 year of experience statistical project management.
• Strong oral and written communication skills.
• Strong organizational and multi-tasking skills.
• Functional understanding of GCP and regulatory requirements.
• Proven track record of collaboration with internal and external partners.

Preferred Qualifications

Biostatistician III:

• 4+ years of relevant work experience.
• Demonstrated specialized knowledge of statistical practice within network specialization.
• Proven track record of collaboration with external collaborators.

Biostatistician IV:

• 5+ years of relevant work experience.
• Demonstrated specialized knowledge of statistical practice within network specialization.
• Proven track record of collaboration with external collaborators.
• 2+ years of experience in a senior, lead or management role.
• 2+ years of experience in statistical project management.
• Functional understanding of network needs and objectives.
• Able to lead network-specific statistical tasks with minimal supervision.

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.

Biostatisticlan III: The annual base salary range for this position is from $93,101 to $139,630, and pay offered will be based on experience and qualifications.  

Biostatistician IV: The annual base salary range for this position is from $104,416 to $165,006, 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). 

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. 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 Data Standards Analyst II.

Under general supervision, the Data Standards Analyst II contributes to the coordination and management of clinical data standards and production of standard datasets within SCHARP. The incumbent provides subject matter expertise in CDISC data standards, supports coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, drafts CRF Global Library form content as well as SDTM and ADaM metadata and conversion specifications, maintains awareness of publication updates from CDISC and other data standards or regulatory agencies that impact SCHARP data standards, and configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse.

Core to the role is a deep understanding of data standards and data transformations, 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

May include some or all of the following:

• Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP Standard SDTM and advises to others in SCHARP on CDASH, SDTM and ADaM standards and processes.
• Works with study teams to lead the definition and documentation of per study SDTM metadata and conversion specifications and ensures alignment with organizational data standards.
• Draft and/or update Study Build Specifications and network Global Library content as needed based on requirements from SCHARP staff and network partners.
• Draft and/or review SDTM metadata and conversion specifications used for SDTM +/- transformations.
• Defines and documents per study clinical data transformations to SDTM+/- from data collection formats such as CDASH.
• Implements clinical data transformations of source data to SCHARP SDTM datasets using database ETL tools. Specifies complex transformations and consults with Programmers, as needed, to implement.
• Reviews and validates derived SCHARP SDTM datasets using Pinnacle 21 to ensure compliance with published specifications.
• Helps provide internal CDISC training to SCHARP and our partners as appropriate and provides routine updates to SCHARP staff to ensure current and new staff are aware of materials and training.
• Participates in process definitions and SOP development as needed.

Qualifications

Minimum Qualifications

• Bachelor’s degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline, and at least two (2) years of experience in data management and/or SDTM implementation and conversion experience,
  • or,
• at least four (4) years of experience in data management and/or SDTM implementation and conversion experience.
• Working knowledge of CDASH, SDTM, and ADaM.
  Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams.
  Experience as a member of a team completing regulatory submissions.
• Experience working with data documentation formats such as CSV, JSON, and XML.
• Expertise using Microsoft Excel.

Preferred Qualifications

• Experience building transformation pipelines using modern ETL tools such as IBM InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other.
• Knowledge of relational database structures and complex data systems.
• Experience programming with a modern procedural, declarative, or statistical programming language such as SAS, Perl, Python, Shell, JEXL, or SQL.
• Experience working in an environment governed by Good Clinical Practices, Good Clinical Data Management Practices, or other FDA guidelines.
• Experience with Electronic Data Capture (EDC) systems, Case Report Forms, and reading study Protocols.

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 this position is from $76,607 to $114,878 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).  

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. 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 IV.

Under minimal supervision, the Senior Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, re-usable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses SAS or R; additional statistical and analytical software programs are used as needed. Central 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.

The Statistical Programmer IV works on complex assignments, shows independence in management of workload and production of quality output, as well as technical expertise that contributes to the programmatic infrastructure of the Statistical Programming group. The Statistical Programmer IV may also mentor and/or supervise junior statistical programmers.

This SCHARP position supports the work of the Vaccine & Immunology Statistical Center (VISC) at Fred Hutch. Since 2005, VISC has partnered with world-class research programs and laboratories to tackle global public health initiatives in HIV, TB, Malaria, and other infectious diseases. VISC is supported by grants from the Bill & Melinda Gates Foundation. VISC works with high-dimensional, next generation sequencing, and multiplex immunological assay data, with the aim of improving our understanding of the immune system and its potential in fighting infectious diseases. VISC's focus encompasses a wide methodological spectrum, ranging from traditional biostatistics to cutting-edge techniques in machine learning and dynamic modeling. Find out more about VISC here (https://ghdiscoverycollaboratory.org/platforms/vaccine-immunology-statistical-center)

Responsibilities

May include some or all of the following:

• 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, lab programmers, statisticians, and other statistical programmers to resolve data quality, processing, and analysis issues.
• 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.
• At least five years of experience in R programming, with additional experience in other programming languages, experience using version control tools (e.g. git or svn).
• At least four years of experience in support of clinical trials, in a clinical research setting or other health research setting, or in data wrangling/transformation within a health-related field.
• 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.
• Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting.
• Knowledge of both SAS and R (including graphics experience) and other programming languages.
• Strong reporting and R package development abilities.
• Advanced R programming skills.
• Ability to use scripting languages for text manipulation and automated job control.

Preferred Qualifications

• Graduate degree in computer science or a scientific, technical, or health-related field.
• 5+ years of statistical programming in a clinical research setting or R programming in a health-related field.
• Knowledge of laboratory and biological assay data.

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 this position is from Level III $94,703 to $149,656 & Level IV $104,416 to $165,006 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).