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IT Specialist SME - Web Content Management System (WCMS)

Akebia Therapeutics

IT Specialist SME - Web Content Management System (WCMS)

Cambridge, MA
Full Time
Paid
  • Responsibilities

    The Principal Statistical Programmer is exceptionally experienced in directing and coordinating the activities of Statistical Programmer to projects.  Work is performed independently with only concept level instruction and very little supervision.  The Principal Statistical Programmer delegates tasks appropriately, tracks progress, and provides expert technical support to team members.  In addition, the Principal Statistical Programmer fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-teams in the role of project lead Statistical Programmer for a large number of studies, including entire development programs.

    Required Skills

    • Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDISC format with minimal instruction or input from supervisor.
    • Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDISC data submission.
    • Participates on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, and acquisition, customization, and integration of new tools and technologies.
    • Conducts briefings and participates in technical meeting for internal and external representatives for projects with more significant consequences and impact.
    • Provide general guidance on definition and documentation of key derived variables needed to support production of TLFs. Assure consistency of data collection and analysis across studies in a project. Assist review of analysis datasets that are quality controlled, sufficient to produce TLFs for reports, compliant with regulatory requirements, and consistent within a project.
    • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Within area of control, update procedures or practices as needed to remain in compliance.

    Required Experience

    • M.S. (or equivalent degree) and 5+ years of relevant work experience or B.S. (or equivalent degree) and 8+ years of relevant work experience.
    • Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
    • Works independently, self-directed, high energy and strong work ethic. High degree of creativity, problem solving, latitude and attention to detail required
    • Ability to work in a small, fast-paced environment covering a range of activities from document creation to agency interactions as the need arises
    • Demonstrated strong project management, teamwork, and interpersonal skills
    • Knowledge of drug development, and biometrics-relevant FDA, EMA and ICH guidelines and regulations.
    • Excellent oral and written communications skills.
    • Expertise in statistical programming, modeling and simulations
    • Understanding of the drug discovery and development process, regionally and globally

     

     

    Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.

    Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

     

    AGENCY AND THIRD PARTY RECRUITER NOTICE:

    Agencies that submit a resume to Akebia for any position posted on our career page must have a current Akebia agency agreement executed by a member of the Human Resource Department.  In addition, agencies may only submit candidates to positions for which they have been invited to do so by an Akebia Recruiter. All resumes submitted outside of these terms will not be considered

  • Qualifications
    • Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDISC format with minimal instruction or input from supervisor.
    • Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDISC data submission.
    • Participates on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, and acquisition, customization, and integration of new tools and technologies.
    • Conducts briefings and participates in technical meeting for internal and external representatives for projects with more significant consequences and impact.
    • Provide general guidance on definition and documentation of key derived variables needed to support production of TLFs. Assure consistency of data collection and analysis across studies in a project. Assist review of analysis datasets that are quality controlled, sufficient to produce TLFs for reports, compliant with regulatory requirements, and consistent within a project.
    • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Within area of control, update procedures or practices as needed to remain in compliance.
  • Industry
    Transportation / Trucking / Railroad