Principal DMC Statistician

The Principal DMC Statistician works primarily in the production and quality control of DMC Charters, DMC analysis plans, DMC summary reports, unblinded tables, listings and figures, provides statistical advice to clients and fulfils the role of the unblinded (independent) biostatistician within a designated project team. In addition, the Principal DMC Statistician is seen as a technical expert and subject matter expert, providing advice on study design, protocol development and a member of the Senior Review pool.

Key Accountabilities;

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

• Act as a member of the Senior Review pool, providing review of statistical analysis plans and tables, listing and figure deliverables throughout GDO; acting as a gatekeeper for statistical precision and quality.

• Coordinate and lead an independent team to successful completion of a DMC within timelines and budget

• Interact with clients as key contact with regard to statistical and contractual issues pertaining to DMCs

• Perform QC of unblinded 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, DMC analysis plans, DMC summary reports and other process supporting documents

• Travel to, attend and actively contribute to all kind of meetings as appropriate (e.g. orientation meetings, presenting, discussing and interpreting study results)

• Support of Business Development; e.g. by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings for potential studies and programs of work

Skills:

• Good analytical skills

• Ability to fluidly communicate statistical concepts in layman's terms required

• Good project management skills

• Professional attitude

• Attention to detail

• Thorough understanding of statistical issues in clinical trials

• Prior experience with R or SAS programming required

• Ability to work independently

• Ability to adapt to dynamic timelines

• Good business awareness/ business development

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

Knowledge and Experience:

• Experience of working with DMCs or similar review committees required

• Experience of working on multiple studies/projects simultaneously is an advantage

• 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