Senior Biostatistician

Woodcliff Lake, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Senior Biostatistician in Woodcliff Lake, New Jersey.  The Senior Biostatistician role oversees CRO programming activities and quality assurance checks, while also acting as the Lead Statistician on complex trials. This position will also act as Lead Representative of the Biostatistics Department as they coordinate with other leaders and managers on project teams. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications
  • Review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
  • Coordinate internal resource utilization for publication and generate activities metrics for management review
  • Work with the clinical study team on study design, development and/or review of clinical study protocols
  • Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed
  • Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality
  • Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables
  • May work with the Health Outcome team on the design/analysis/validation of projects
  • May work on submission teams as a statistician and/or a programmer
  • Act as lead Statistician on complex trials and across multiple studies
  • Act as a lead representative of the of the biostatistics department on project teams

EXPERIENCE

  • Minimum 3-5 years of SAS programming
  • Oncology experience is highly preferred
  • Good technical writing skills required

EDUCATION

  • Must have a MS in Biostatistics/Statistics with at least 10-12 years of experience or a PhD in Biostatistics/ Statistics with at least 6 years of experience in the pharmaceutical, CRO or biotech industry

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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