Biostatistics Data Manager, Level I-II

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The Biostatistics Data Manager I-II is responsible for all activities related to IXRS List Loads including data management, specification review, list analysis, documentation, quality checks, load execution, consultancy and administration.
 
Responsibilities include but are not limited to:
 
Data Management of Externally Generated Lists:
  • Receive lists from clients or 3rd parties and securely store
  • Provide receipt confirmation of lists received
  • Analyze lists by generating List Summary Report through SAS programming (including number ranges, counts, format, descriptions, assessment for duplicates)
  • Review relevant IXRS Requirements to ensure accuracy of list specifications / import details, codes / descriptions (e.g., Treatment / Kit / Stratum), unblinding risk assessment, and list / IXRS compatibility)
  • Perform Quality Check(s) (QC) of relevant data management tasks
IXRS List Loads (Randomization, Clinical Supplies Kit, Others; Internally / Externally Generated List Files):
  • Prepare List Load materials (including documentation, data file administration)
  • Perform database queries via SQL programming to ensure IXRS readiness for List Load procedures
  • Execute IXRS Import of List Data Files (Randomization, Clinical Supplies Kit, Others)
  • Complete required List Load documentation
  • Perform QCs of List Load materials / procedures / documentation
  • Facilitate post-load approval (as required) 
List Consultancy:
  • Provide internal / external advisement on list structure / format, randomization implementation, unblinding risks, etc.
  • Respond to any questions / queries in regard to List Load activities
Project Coordination / Administration / Management:
  • Maintain tracking database with List Load activities / timelines
  • Coordinate List Load schedule for project with relevant team members
Biostatistician Support:
  • Provides assistance to ACT Biostatisticians as needed for standard tasks including List Generation Documentation, List Generation (SAS programing), pre-load approval / delivery facilitation, Randomization Reviews, QCs, etc.
Additional Functions:
  • Meet regularly with Biostatistics team members to assess workload to ensure timelines are met
  • Ensure Biostatistics Management are informed of project work progress and any issues
  • Provide support in process improvements to increase efficiency and accuracy
  • Provides support within the group and cross functionally as identified by Biostatistics Management
  • Assist with preparation / delivery of training materials related to the Biostatistics activities
  • Continued Biostatistics knowledge development (e.g., group discussions, literature review, presentations, conferences, courses, workshops)
Behavioral Requirements:
  • Very high attention to detail skills are essential
  • Ability to handle multiple responsibilities and job tasks (multi-tasking)
  • Flexible with work requirements and fast-paced/changing job needs
  • Ability to self-manage changing priorities, and track completed / upcoming tasks
  • Effectively be able to both deliver and receive feedback in a professional manner
  • Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change
  • Ability to think critically and work independently
Required Education
  • Associate’s degree with a minimum of two (2) years of industry related experience or Bachelor's degree
Preferred Education:
  • Bachelor's degree in Biostatistics, Statistics, Mathematics, Information Systems (or related field)

Required Work Experience:

  • 1+ year professional work experience

Preferred Experience:

  • 1+ year professional work experience in the pharmaceutical, clinical trials, research, health care, data management, SAS programming or related field

Required Knowledge:

  • Proficient knowledge of Microsoft Office products
  • Basic data management or informational systems knowledge
  • Basic knowledge of clinical trials

Preferred Knowledge:

  • Clinical trials
  • Randomization in clinical trials
  • Experience with SAS (or equivalent statistical software) and SQL programming

Skills:

  • High attention to detail and ability to work accurately with data and information
  • Basic programming skills / math competency
  • Strong communication (written and verbal), interpersonal, excellent presentation and customer service skills
  • Strong time management and organizational skills, ability to perform multiple project tasks, and ability to cope with reactive nature of the role
  • Ability to operate in project team environment
 
 
 
 
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