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11 days old

Associate Director - Statistics (Oncology)

Kelly Services
Indianapolis, IN 46202
**Kelly Science is looking for an Associate Director in the area of biostatistics. Looking for an experienced candidate in area of oncology drug development within a pharmaceutical or biotechnology company.**


**Associate Director - Biostatistics - Oncology Area**


**Direct Hire, Remote**


**Statistical expertise in the design, analysis, and interpretation of clinical trial programs**


+ Submission and defense of regulatory filings; and the generation of evidence to support product commercialization and reimbursement.

+ Work cross-functional teams on multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.


**Objectives:**


**Apply expert skills to investigate and use novel, statistical approaches for relevant statistical issues.**


+ This includes application of modelling and simulation to improve study design, and identification of opportunities to improve statistical methodology and/or provide practical solutions for problems.

+ Conduct analyses of internal and external information to inform design decisions and the development of decision criteria.

+ Authors study Statistical Analysis Plans SAPs, including table, figure, and listing TFL shells.

+ Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.

+ Interpret study results and provide review of statistical summary reports to study results.

+ Plays a critical role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.

+ Contributes to the development of best practice to improve quality, efficiency and effectiveness.


**Requirements:**


+ PhD in statistics or biostatistics with at least 7 years of relevant experience or MS in statistics or biostatistics with at least 10 years of relevant experience.

+ Experience in using or sound understanding of the value of Bayesian methods in scientific research preferred.

+ Prior experience providing statistical support to early phase clinical studies preferred.

+ Strong computational skills in R or SAS or other statistical applied software systems.

+ Experience in oncology drug development within a pharmaceutical or biotechnology company is required.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-29 Expires: 2022-08-29

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Associate Director - Statistics (Oncology)

Kelly Services
Indianapolis, IN 46202

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