Biostatistician 2

About the Role

The Biostatistician 2 will support Emerald Clinical projects by performing statistical programming and biostats activities as directed by senior management or a senior statistician at Emerald Clinical.

Your Responsibilities

• Perform, plan co-ordinate, and implement the following for complex studies:
• Participate as biostatistician on project(s) including but not limited to reviewing protocols, preparing analysis plans, randomization plan, and writing sections of joint clinical/statistical reports.
• The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures and listings.
• Programming SDTM datasets.
• Programming analysis datasets (derived datasets including efficacy datasets) and transfer files for internal and external clients.
• The programming quality control checks for the source data and report the data issues periodically
• Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
• Directly communicate with internal team including data management, project management, and client statisticians and client team members to ensure appropriate understanding of requirements and project timelines.
• Use and promote the use of established standards, SOP and best practice.
• Participate in project meetings; keep up-to-date on project issues;

Training, Quality and Compliance

• Complete mandatory training for this role within specified timelines
• Attend mandatory training sessions required for this role
• Identify resources and training to support learning and development within this role
• Comply with all applicable regulations, guidelines, SOPs and project-specific requirements
• Comply with all designated systems relevant to this role
• Ensure own quality control of all relevant processes and activities performed
• Report and escalate identified risks and issues in areas of responsibility according to George Clinical and/or project requirements

Customer Focus and Teamwork

• Attend and actively participate in Emerald Clinical meetings and other internal meetings and activities as required
• Provide input to systems, tools and processes to support continuous improvement Share knowledge with others, to facilitate learning and development across the organization

Work Health and Safety

• Comply with Work Health Safety (WHS) legislation and operate in accordance with established organisational WHS practice and procedures
• Promote and contribute to a safe, secure environment for staff and visitors

Education and Experience

• M.Sc or Ph.D. in Biostatistics, Maths or science related field
• Minimum 6 years experience with statistical programming and/or 3 years in the Biostatistics or related work in the CRO environment
• Minimum 7-8 years experience in the CRO/Pharma environment.
• Technological proficiency in SAS

Competency

• Ability and motivated to learn and develop
• Good team work and willing to help other team members.
• Technological proficiency including Microsoft Office packages
• Ability to see the big picture, yet still focus on detail and quality of work
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.