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Principal Biostatistician

Durham, NC

Posted: 08/19/2020 Employment Type: Direct Hire Job Category: Clinical: Biometrics Job Number: 2595

Job Description

The Principal 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. The Principal Biostatistician successfully supports Biostatistics leads and senior reviewers in the execution of deliverables by managing the timelines and budget of assigned tasks. This individual supports Business Development by assisting with Biostatistics costs for proposals, and attending bid defense and capabilities meetings when required.

Additionally, the Principal Biostatistician prepares specifications for analysis data sets and independently drafts statistical analysis plans. This individual also acts as Lead Biostatistician on assigned projects, interacts with the study team and the Sponsor, and is responsible for tracking project revenue, backlog, and hours worked on projects, and will forecast the necessary hours to complete a project. In addition, he/she also supervises SAS programming and program validation for projects.


The Principal Biostatistician:
  • 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
  • Supports Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development.
  • Acts as an independent Biostatistician on DSMBs and DMCs
  • Acts as Project Manager for one Biostatistics stand-alone project


For project success:
  • 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
  • Facilitates resolution of project related conflicts with necessary corrective action and alerts senior management to potential issues
  • Develops strong relationships with current clients to generate new and/or add-on business for the future

For commercial success:
  • 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
  • Tracks hours by keeping detailed records of hours worked on projects for accurate billing and to forecast hours to complete
  • Provides support for audits
  • Participates in and contributes to the training and development of new Biostatisticians
  • Participates in efforts for efficiency and productivity in the department
  • Attends project team and other company meetings, as required
  • Participate in corporate initiatives and actions that ensure the continued success of the company
  • Performs other work-related duties as assigned

  • Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field
  • Experience
  • 6-8 years of experience in clinical trials design and analysis using SAS
  • Prior experience using computerized information systems preferred.
  • 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.
  • Works with internal and external customers/vendors to meet project specific goals.
  • Identifies, monitors, documents, and tracks out-of-scope activities.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook Evidence of good SAS programming skills
  • Knowledge of web based communication tools for conferences
  • Evidence of advanced SAS programming skills
  • Fluent verbal, written, and interpersonal English as well as the local language(s) required for clinical trial submissions.
  • Excellent team player, collaborative and able to build an effective team.
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Strong verbal and written communication and negotiation skills.
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines.
  • Accountable, dependable and strong commitment.
  • Is customer service focused in approach to work both internally and externally.
  • Maintains a positive, results orientated work environment.
  • Ability to build client confidence and achieving high levels of customer satisfaction
  • Ability to communicate basic statistical concepts to other scientists and nonscientists
  • A willingness to travel, ~20%

Meet Your Recruiter

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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