Senior DMC Statistician
Job Details
Full Job Description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the
world's health. From clinical trials to regulatory, consulting, and
market access, every clinical development solution we provide is
underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Senior 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 Senior 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