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Become A Principal Biostatistician

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Working As A Principal Biostatistician

  • Analyzing Data or Information
  • Interacting With Computers
  • Processing Information
  • Communicating with Supervisors, Peers, or Subordinates
  • Interpreting the Meaning of Information for Others
  • Mostly Sitting

  • $80,110

    Average Salary

What Does A Principal Biostatistician Do At Regeneron Pharmaceuticals

* With periodic supervision and guidance from senior departmental staff, provide support and leadership to a clinical study team on all relevant statistical matters.
* Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis
* With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments.
* Perform relevant sample size calculations.
* Develop statistical analysis plan (SAP).
* Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned TFL.
* Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the study team to move the CSR through review and approval process.
* Provide statistical insight into interpretation and discussion of study results.
* Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or independent monitoring committees.
* Provide assistance to project statistician or Therapeutic Area lead biostatistician in project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.
* Active research interest in area related to clinical trial.
* Adheres to procedures surrounding retention of data, records, and information for clinical studies

What Does A Principal Biostatistician Do At Seattle Genetics, Inc.

* Provide leadership to the biometrics team on one or more clinical programs or key studies; review work of statisticians supporting this work
* Provide update to management on program progress with focus on biometrics
* Collaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designs
* Perform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a design
* Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements
* Design and write statistical sections for clinical trial protocols or oversee this work
* Generate study randomizations and provide inputs on maintaining study blinding
* Develop statistical analysis plans for clinical trials or oversee this work
* Write statistical sections of regulatory submissions or oversee this work
* Design and conduct statistical analysis of clinical data or oversee this work
* Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
* Represent Seattle Genetics statistical position to regulatory agencies
* Key contributor in project planning
* Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
* Become knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
* Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
* Knowledge of FDA regulations, ICH GCP guidelines, the drug development process

What Does A Principal Biostatistician Do At Boehringer Ingelheim

* Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required.
* Collaborate with members of Clinical Research and Marketing, Trial Clinical Monitor and trial teams incl. pharmacokineticist in planning clinical trials and protocols conforming to company and regulatory agency guidelines and/or marketing and publication strategies.
* Act as Project Statistician for early projects, backup projects,or projects with established BI experience.
* Support Project Statisticians of high profile international projects in their responsibilities, especially in their statistical responsibilities in the planning and preparation of regulatory submissions and contribute to efforts on cross-trial planning and harmonization.
* Analyze data from phase I to IV trials incl. responsibility for program validation.
* Perform exploratory analyses in collaboration with the Project Statistician.
* Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management.
* Prepare specifications for data analyses by outside vendors as required.
* Assure compliance with the specifications by reviewing the vendors' products.
* Participate on assigned international teams to promote harmonization efforts for clinical drug development.
* Support management in resource planning and tracking for assigned trials and projects.
* Act as a team leader for a complex project or mega-trial who
* Ensures team members adhere to the SOPs, guidelines and local working instructions.
* Attends all the meetings related to the trial/project needing a statistical input (or send delegates) and send minutes to the team members
* Assist the Head of programming and Head of statistics with the working of vendors, contractors in establishing procedures for programming and validating statistical analysis (writes the scope of work, prepare documents to be sent to the contract research organization (CRO).
* From a statistical perspective, is the primary contact for CROs (programming validation)
* Acts as a Trial or Project Statistician (TSTAT or PSTAT) for the trial/project.
* In particular, develops report and programming specifications in a Trial Statistical Analysis Plan (TSAP) and update this document as often as needed.
* Collaborate with the programming group and the data management group to submit very detailed timelines for the trial/project to clinicians.
* Meeting agreed upon timelines are essential to the success of the clinical trial/project team objectives
* From a statistical perspective, is the primary contact for medical writing (or choose a designee)
* Ensures that protocol objectives are met and project standards are maintained (also responsible to update the project statistical analysis plan when necessary
* Ensures achievement of major statistical deliverables and milestones in coordination with other functions including Clinical Research, Safety, Statistical Programming, Data Management and Medical Writing
* Provides and organizes statistical support for regulatory meetings, questions and submissions.
* Informs management that hours allocated to TSTAT by the capacity algorithm should be updated (follow up the amount of hours entered in the time recording system and related to the trial/project)
* Ensures efficient work within the team by setting priorities and avoiding overlaps between team members
* Works directly and proactively with the Trial, Project or Substance team.
* Assumes responsibility for the coordination of all relevant statistical activities for a Trial, Project or Substance.
* Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status.
* Alerts management in case of resources issues, timelines problems or conflicts within the team
* In collaboration with the statistical expert group member, maintain expertise in therapeutic area, by keeping abreast of new publications with the purpose of increasing the overall efficiency or effectiveness in the department

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How To Become A Principal Biostatistician

Statisticians typically need at least a master’s degree in statistics, mathematics, or another quantitative field. However, a bachelor’s degree is sufficient for some entry-level jobs. Research and academic jobs generally require a Ph.D.

Education

Statisticians typically need at least a master’s degree, although some entry-level jobs are available for those with a bachelor’s degree. Most statisticians have degrees in mathematics, economics, computer science, or another quantitative field. A bachelor’s degree in statistics typically includes courses in linear algebra, calculus, experimental design, survey methodology, probability, and statistical theory.

Many colleges and universities advise students to take courses in a related field, such as computer science, engineering, physics, or mathematics. These courses can help prepare students to work in a variety of industries. Coursework in engineering or physical science, for example, may be useful for statisticians working in manufacturing on quality or productivity improvement. A background in biology, chemistry, or health sciences is useful for work testing pharmaceutical or agricultural products.

Because statisticians often work with data analysis software, computer programming courses may be particularly beneficial for students.

Important Qualities

Analytical skills. Statisticians use statistical techniques and models to analyze large amounts of data. They must determine the appropriate software packages and understand computer programming languages to design and develop new techniques and models. They must also be precise and accurate in their analyses.

Communication skills. Statisticians often work with, and propose solutions to, people who do not have extensive knowledge of mathematics or statistics. They must be able to present statistical information and ideas so that others will understand.

Math skills. Statisticians use statistics, calculus, and linear algebra to develop their models and analyses.

Problem-solving skills. Statisticians must develop techniques to overcome problems in data collection and analysis, such as high nonresponse rates, so that they can draw meaningful conclusions.

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Principal Biostatistician jobs

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Principal Biostatistician Demographics

Gender

  • Male

    70.6%
  • Female

    17.6%
  • Unknown

    11.8%

Ethnicity

  • White

    51.6%
  • Asian

    30.3%
  • Hispanic or Latino

    13.3%
  • Unknown

    3.8%
  • Black or African American

    1.0%
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Principal Biostatistician

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Principal Biostatistician Education

Principal Biostatistician

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Real Principal Biostatistician Salaries

Job Title Company Location Start Date Salary
Principal Biostatistician Biomarin Pharmaceutical, Inc. Brisbane, CA Mar 04, 2015 $150,000 -
$168,000
Principal Biostatistician Parexel International Billerica, MA Feb 10, 2016 $146,545
Principal Biostatistician Vertex Pharmaceuticals Incorporated Boston, MA Apr 07, 2014 $145,000 -
$155,000
Principal Biostatistician Biomarin Pharmaceutical Inc. Novato, CA Jun 24, 2013 $137,000 -
$168,000
Principal Biostatistician Parexel International Billerica, MA Oct 01, 2015 $136,723
Principal Biostatistician Millennium Pharmaceuticals, Inc. Cambridge, MA Jul 23, 2012 $136,000
SR. Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Jan 10, 2016 $131,919
Principal Biostatistician Parexel International Billerica, MA Mar 14, 2014 $130,835
Principal Biostatistician Janssen Research & Development, LLC Raritan, NJ Oct 11, 2014 $130,600
Senior Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Nov 19, 2014 $130,087
SR. Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Jun 09, 2016 $127,000
Senior Principal Biostatistician, Oncology Global DEV Novartis Pharmaceuticals Corporation East Hanover, NJ Nov 19, 2014 $124,484
Senior Principal Biostatistician, Oncology Global Development Biostatistics Novartis Pharmaceuticals Corporation East Hanover, NJ Feb 12, 2015 $124,484
Senior Principal Biostatistician, OGD Novartis Pharmaceuticals Corporation East Hanover, NJ May 04, 2015 $124,351
SR. Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Oct 01, 2014 $124,000
Principal Biostatistician, Global Biometric Scienc Bristol-Myers Squibb Company Wallingford, CT Mar 10, 2014 $123,885
Principal Biostatistician, Global Biometric Scienc Bristol-Myers Squibb Company Wallingford, CT Sep 25, 2013 $123,885
Principal Biostatistician Bristol-Myers Squibb Company Pennington, NJ Sep 17, 2010 $123,776
Senior Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Aug 28, 2016 $123,041
SR. Principal Biostatistician Novartis Pharmaceuticals Corporation Florham Park, NJ Sep 15, 2012 $114,632
SR Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Nov 25, 2016 $114,000
Senior Principal Biostatistician, Neuroscience Novartis Pharmaceuticals Corporation East Hanover, NJ Jun 17, 2011 $113,344
SR Principal Biostatistician Novartis Pharmaceuticals Corporation Florham Park, NJ Oct 01, 2013 $113,152
SR Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Oct 01, 2013 $113,152
SR. Principal Biostatistician Novartis Pharmaceuticals Corporation East Hanover, NJ Aug 05, 2013 $113,000
SR. Principal Biostatistician, Clinical Pharmacology, Novartis Oncology Novartis Pharmaceuticals Corporation East Hanover, NJ Oct 02, 2014 $113,000

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Top Skills for A Principal Biostatistician

StatisticalAnalysisPlansStatisticalAnalysisSolutionsRegulatoryAuthoritiesClinicalTrialDeliverablesStatisticalMethodsProtocolFDACRFCROStatisticalSectionsStatisticalSupportIIIPhaseI-IVExploratoryAnalyses/GraphicsBiomarkerExperimentsCompanyStandards/ProcessesStatisticalReportsQCEUCTT

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Top Principal Biostatistician Skills

  1. Statistical Analysis Plans
  2. Statistical Analysis Solutions
  3. Regulatory Authorities
You can check out examples of real life uses of top skills on resumes here:
  • Developed and reviewed Statistical Analysis Plans (SAP) with the team.
  • Provide statistical analysis solutions when exploratory analyses are required.
  • Ensured that Questions from regulatory authorities were answered appropriately.
  • Advised clinicians, toxicologists, and field veterinarians on statistical methods for field, clinical, and laboratory studies.
  • Support the protocol writing by providing statistical computational solutions for scenarios simulations and sample size calculations.2.

Top Principal Biostatistician Employers