Senior Biostatistician

Key Accountabilities:

Operational Execution:

· Coordinate and lead a project team to successful completion of a project within timelines and budget

· Interact with clients as key contact with regard to statistical and contractual issues

· Perform QC of derived datasets, tables, figures and data listings produced by other members of the department

· Check own work in an ongoing way to ensure first time quality

· Understand and apply advanced statistical methods

· Lead production and quality control of randomizations, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents

· Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review

· Travel to, attend and actively contribute to all kind of client meetings as appropriate (eg discussing analysis concepts, presenting, discussing and interpreting study results)

Business Development:

General Activities:

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.

• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.

• Proactively participate in and/or lead process/quality improvement initiatives.

• Provide consultancy to internal and external sponsors with regard to statistical programming tasks.

• Represent PAREXEL at sponsor marketing and technical meetings.

• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Skills:

· Good analytical skills

· Good project management skills

· Professional attitude

· Attention to detail

· Thorough understanding of statistical issues in clinical trials

· Prior experience with SAS programming required

· Ability to work independently

· Good leadership skills

· Good business awareness/ business development

· Willingness to work in a matrix environment and to value the importance of teamwork

• Demonstrate commitment to refine quality processes.

Knowledge and Experience:

· PhD in Statistics or related discipline with some experience or MS in Statistics or related discipline with significant experience

· The knowledge of pharmacokinetic data is an advantage

· Competent in written and oral English in addition to local language

Education:

· PhD in Statistics or related discipline, MS in Statistics or related discipline