Biostatistician Lead

Kelly’s Outsourcing & Consulting Group is seeking a Lead Biostatistician for an open-ended, benefitted assignment in Irvine, CA.  The Lead Biostatistician will be responsible for leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives, as well as providing guidance on standards, processes, and technical topics within the statistics team.  His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post- market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets.

 

Responsibilities:

  • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
  • Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
  • Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
  • Generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.
  • Review and assess protocol deviations to the extent that they affect statistical analyses.
  • Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
  • Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
  • Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
  • Assist with preparation of documentation for IRB/Ethics Committee submissions.
  • Act as a statistical consultant to the business units and external customers on statistical issues.
  • Interface with surgeons to assist in drafting peer-reviewed journal articles.
  • Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables.
  • Provide statistical reports for data quality/performance metrics.
  • Assist Clinical Research with literature reviews and other activities.
  • May assist in presenting information at professional meetings.
  • May oversee the statistical deliverables produced by lower-level biostatisticians or external consultants.
  • May oversee production of presentation materials for presentations at professional meetings.
  • Stay current with statistical methodology in clinical trial design and analysis.
  • Assist in the preparation and documentation of results to support trial reports and publications.

 

Qualifications:

  • A Master’s or Ph.D degree in Statistics, Biostatistics, or Applied Mathematics
  • 5-10 years of experience performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area.
  • Demonstrated technical experience in preparing statistical deliverables on time.
  • Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, parametric, non-parametric, and multivariate statistical tests is required.
  • Ability to assist in selecting and defining independent and dependent variables in the field of application is preferred.
  • Ability to contribute to strategic planning
  • Experience with survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies is required.
  • Knowledge of Bayesian statistics OR meta-analyses is preferred
  • A thorough understanding of covariate analyses is required
  • Excellent verbal and written communication skills is required
  • Knowledge of Microsoft Word is required
  • Proficiency in SAS is required
  • Familiarity with other statistical packages for handling smaller datasets and power analyses is preferred.
  • Research and experience with peer-reviewed journal publication are preferred.
  • Neurovascular research experience is preferred for the position based in Irvine.
  • Medical device experience is preferred.

 

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

 

This position comes with enhanced benefits which include:

  • 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
  • Paid holidays
  • Paid sick days and vacation days*

 

Perks of being a Kelly employee:

  • Weekly electronic pay
  • Access to more than 3,000 online training courses though Kelly Learning center
  • Online application system
  • Never an applicant fee

 

*benefits to be received upon meeting eligibility requirements

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

Why Kelly®?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services┬« workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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