Careers

The Statistical Research Associate provides low advanced-level statistical support in the planning, operations, monitoring, analytic, and exploratory stages of clinical trials and research. Job duties may include some or all of the following:

• Collaborate with PhD statisticians/epidemiologists, 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 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 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 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

Minimum qualifications

• 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

• 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 supervisio