Senior Statistician, Remote

Marietta, GA

Contract To Perm

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OVERVIEW

The Senior Biostatistician generates derived datasets, tables, listings, and figures (TLFs) of clinical trial data, performs quality control of TLFs and derived data sets created by other Biostatisticians, and may be asked to assist in the preparation of statistical plans. This role may be located at our Client’s location in either Pennsylvania, North Carolina, Illinois, or may be done remotely. The Biostatistician successfully supports Biostatistics leads and senior reviewers in the execution of deliverables by managing the timelines and budget of assigned tasks. 

RESPONSIBILITIES

  • Independently develops SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan
  • Performs QC of TLFs, CDISC and other analysis data sets
  • Prepares specifications for CDISC and other analysis data sets
  • Independently develops statistical analysis plans
  • Acts as Lead Biostatistician to interact with the study team and the Sponsor
  • Develops and maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
  • Keeps detailed records of time spent on each project to allow accurate billing 
  • Respects and maintains the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with 
  • Maintains Biostatistical section of TMF 
  • Reviews and provides feedback on Data Management documents 
  • Reviews study protocols
  • Provides statistical input to Clinical Trial Reports
  • Ensures work completed is completed is on time at the correct level of quality
  • Builds strong relationships with Data Management to provide proactive support
  • Tracks project revenue and backlog
  • Provides support for audits 

EXPERIENCE

  • At least 4 years of experience in clinical trials design and analysis using SAS
  • Ability to read, write, and speak fluent English; fluent in host country language
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook 
  • Evidence of good SAS programming skills
  • Knowledge of web based communication tools for conferences
  • Fluent verbal, written, and interpersonal English as well as the local language(s) required for clinical trial submissions

EDUCATION

  • Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field

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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