Senior Principal Statistician Job in Gaithersburg, Maryland US
At Kforce Clinical Research, we don't just offer jobs.
We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the world's most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies.
Using these tools, Kforce is able to better plan and anticipate workloads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home.
Currently, one of our top clients is in search of an exceptional Senior Principal Statistician in Gaithersburg, MD. Specific Accountabilities: Participate and provide strategic statistical and scientific inputs into clinical development planning or jointly author the plans with Medical DirectorsParticipate therapeutic area strategic and tactical meetings contribute to strategic planning to ensure statistically optimized clinical development plans and provide presentations if neededBe responsible for the statistical designs of clinical trial and create statistical sections for study synopses and protocolsLead Biostatistics activities for the regulatory submission documents including summaries of clinical safety and efficacy of BLA/NDAs if needed review protocols study reports and submission documentsCreate statistical documents including CRF specifications document statistical analysis plan and statistical programming plan with templates for table listings and graphs, etc.Provide statistical input/contributions to regulatory submissions and interactions response to questions from the FDA and Advisory Committee meetings if neededRepresent biostatistics in project team meetings and other project activitiesPresent statistical considerations at investigator or other external meetingsRequirements: MS or PhD in Statistics or related fieldIndustry experience in clinical trial environment: approximately 6 (for PhD) or 9 (for MS) yearsOncology or vaccine clinical trial experience preferredDue to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria.
Kforce Clinical Research has been serving the pharmaceutical industry since 1988.
We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect.
If you are qualified and interested in the excellent career opportunities we have for you, apply today!
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