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Oncology Biostatistician - Remote

Cancer Insight Los Angeles ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

CANCER INSIGHT (CI) JOB DESCRIPTION

Biostatistician

REPORTS TO: Chief Operating Officer and Chief Projects Officer

OVERVIEW:

As the experienced Biostatistician for Cancer Insight, the person in this role will lead study design and biostatistical strategies, provide input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manuscripts. As the lead statistical support for all of Cancer Insight’s clinical trials this role interacts and consults with clinical and project teams to ascertain their needs and develop an appropriate design and statistical solutions. Writes statistical analysis plans and reports for use by internal and external sponsors. Critiques and improves study designs developed across the organization. Has primary ownership for statistical support of all major projects and actively mentors less experienced colleagues as needed.

This is a remote work from home position.

RESPONSIBILITIES:

  • Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical outcomes.

  • Writes statistical analysis plans as needed to capture design elements and statistical methodology.

  • Perform statistical activities in support of development and medical affairs studies, including development of study design and protocol, development of statistical analysis plans, data analysis, algorithm development, preparation of final study reports, abstracts, posters, and manuscripts.

  • Represent the statistics function on project teams for clinical development programs, providing strategic input and contributing significantly to the design of clinical studies and the clinical development plan.

  • Performs statistical analyses and prepares statistical reports of results.

  • Reviews statistical analyses conducted by statistical programmers and other biostatisticians to ensure accuracy and quality.

  • Conducts randomization and blinding of samples.

  • Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization.
  • Maintains expertise in state-of-the-art data manipulation and statistical analyses, and mentors less experienced colleagues.

  • Manages day-to-day operational aspects of a project.

  • Monitors work to ensure quality.

  • Develop Biostatistics Department Standard Operating Procedures (SOPs)

EDUCATION/EXPERIENCE/SKILLS:

  • Knowledge of FDA guidelines for in vivo therapeutics and diagnostic devices, with a particular focus on the field of oncology, and the required statistical basis for sample size estimation, sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval.

  • Strong ability to collaborate across departments and interact with various levels in the organization.

  • High attention to detail with skill in producing organized reports.

  • Ability to write statistical code and documentation.

  • SAS coding experience

  • Ability to work in a team-focused remote environment.

  • Ability to prioritize and plan work activities independently.

  • Ph.D. in Biostatistics or Statistics

  • 1+ years Experience with biostatistics associated with clinical trials, particularly in oncology.

  • Knowledge of CDISC Data Standards: SDTM and ADaM

 

Company Description
Cancer Insight is a Clinical Research Organization dedicated to discovering, developing, and testing emerging biotechnologies related to cancer therapies.

We believe new advancements and new technologies will be born out of ingenuity, expertise, and focused resolve. Reshaping how we think about cancer in order to reshape what we think about cancer – transforming impossibility into hope.

Cancer Insight is continuing over a decade of cancer immunotherapy research and testing developed under the military program Cancer Vaccine Development Program. Our seasoned research team, led by Dr. George Peoples, will continue to operate with the same focus, integrity and innovation to push new technologies and advance vaccine research. We have brought together decades of academic experience with business professionals in the private sector to both develop and test safe and efficient therapies and preventative strategies.

Cancer Insight

Why Work Here?

Mission driven small company focused on changing the future of cancer care. Remote work with ample flexibility.

Cancer Insight is a Clinical Research Organization dedicated to discovering, developing, and testing emerging biotechnologies related to cancer therapies. We believe new advancements and new technologies will be born out of ingenuity, expertise, and focused resolve. Reshaping how we think about cancer in order to reshape what we think about cancer – transforming impossibility into hope. Cancer Insight is continuing over a decade of cancer immunotherapy research and testing developed under the military program Cancer Vaccine Development Program. Our seasoned research team, led by Dr. George Peoples, will continue to operate with the same focus, integrity and innovation to push new technologies and advance vaccine research. We have brought together decades of academic experience with business professionals in the private sector to both develop and test safe and efficient therapies and preventative strategies.

Address

Los Angeles, CA
USA

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