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16 days old

Principal Biostatistician

Kelly Services
Culver City, CA 90231
Kelly Scientific is seeking a Principal Biostatistician for a fully remote, direct hire (perm) opportunity **to act as** an expert in the design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company

strategic objectives are met.



**ESSENTIAL FUNCTIONS**


+ Lead all aspects of the statistical analysis

+ Contribute to the design of phase I-III clinical trials including sample sizecalculations, interim analyses, DMC activities, and randomization procedures

+ Contribute to the development of clinical trial protocols and clinical study reports;write the statistical methodology section of these documents

+ Prepare statistical analysis plans, statistical output shells, and analysis datasetspecifications

+ Contribute to the creation, validation, traceability, reproducibility, andmaintenance of the analysis datasets and statistical outputs

+ Contribute to the electronic submission of clinical trial data to regulatoryauthorities

+ Proactively solve problems of statistical complexity

+ Provide input or lead data standardization efforts (CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC SDTM/ADaM, and e-submissions)

+ Participate effectively as a key member of clinical study teams

+ Provides analytical insight on statistical methodology and advice to internal teams of accordingly

+ Keep current with new clinical trial designs and statistical methodology

+ Provide work direction, guidance, mentoring, influence, and support tojunior staff. Train junior staff in more complex statistical methodology.


**QUALIFICATIONS**


+ Masters Degree in Statistics or Biostatistics

+ 8+ years of experience as a biostatistician in the pharmaceutical industry

+ Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines

+ Proficient in SAS; familiar with sample size software such as nQuery or PASS

+ Experience as a lead biostatistician on several concurrent projects

+ CDISC STDM/ADaM experience

+ Excellent English verbal and written communication skills; good organizational and interpersonal skills


Equal Opportunity Employer and will not discriminate against any applicant for employment based on race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity.


\#TJP2022_SPEC


**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)

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Posted: 2022-05-06 Expires: 2022-06-06

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Principal Biostatistician

Kelly Services
Culver City, CA 90231

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