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Principal SAS Programming

Company: Katalyst Healthcares & Life Sciences
Location: Pleasanton
Posted on: January 23, 2023

Job Description:

Responsibilities:


  • As a clinical trial lead statistician, familiarize with the workflow of statistical related process in clinical trials, plan and complete statistical analysis plan, use SAS programming to produce TFL outputs; familiarize with and support data collection and management related statistical tasks in clinical trials, including completion of case report form CRF, data management plan DMP, data validation plan DVP, protocol deviation specification DVP, and data transfer agreement DTA, etc;
  • Support protocol writing and review to provide a blueprint for development of SAP; support protocol amendment, including the communication of modifications and justifications with regulatory agencies.
  • To streamline and optimize the working process in the department as requested, propose actionable suggestions.
  • Independently complete various types of statistical jobs, including sample size calculation, development and implementation of randomization, development of statistical analysis plan and TFL mock shell, development of statistical analysis report and clinical study report, and other statistical related documents with quality assurance of each document; guide junior statisticians on related jobs through document review.
  • Be responsible for project management in terms of timeline and budget, execute the plan after alignment with all stakeholders; organize, coordinate and participate internal and external communications to ensure the smooth conduct of the project on time and within budget; participate in project meetings, such as protocol discussion meeting, data review meeting, statistical analysis discussions meeting.
  • Independently support pre-sale biding activities, including statistical consultation of clinical trial study design, selection of statistical analysis methods, prepare bid defense meeting presentation slides, respond to client's questions to assist business development.
  • Follow SOP, ICH-GCP and other applicable regulatory guidelines in daily work; constantly review and summarize personal work and ensure the first-time quality.
  • Deliver various statistical analysis results with high standards and quality.
  • Perform QC of analysis specifications, derived datasets, Tables, Listings, Figures (TLFs).
  • Familiar with the frequently used clinical trial related laws, regulations, requirement, guidance of specific therapeutic areas, statistical analysis and/or programming methods, and share to other staffs in the department for learning; share knowledge or provide training with regard to statistics and/or statistical programming and provide guidance and mentoring to other staffs in the department.
  • Additional responsibilities as needed in the department.

    Requirements:


    • Master's or PhD degree in mathematics, statistics, biostatistics or related area or equivalent work experience with master's degree with 4-6 years of experience with solid understanding of statistical knowledge.
    • Be familiar with clinical biostatistics work and proficient in SAS programming to produce TLFs.
    • Familiarize with different types of interim analysis in clinical trials, including the reason of conduction, objectives, process and analysis methods.
    • Well experienced in project management and perform various statistical analysis independently.
    • Be familiar with applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and various guideline on clinical trial evaluation and conduction from regulatory agencies; Be familiar with common statistical analysis concepts and methods in clinical studies.
    • Familiar with the clinical data standards on submission, such as CDISC.
    • Good statistical skills and thinking, professional working attitude detail-oriented, good teamwork and problem-solving ability.
    • Excellent written and oral English communication skills including grammatical/technical writing skills.
    • Good leadership skills.

Keywords: Katalyst Healthcares & Life Sciences, Pleasanton , Principal SAS Programming, Other , Pleasanton, California

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