Biostatistician Job Description

Biostatistician Job Description

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Biostatistician provides SAS programming and statistical support to Senior Biostatisticians and researchers primarily involved in non-clinical research.

Biostatistician Duties & Responsibilities

To write an effective biostatistician job description, begin by listing detailed duties, responsibilities and expectations. We have included biostatistician job description templates that you can modify and use.

Sample responsibilities for this position include:

Follow processes and adhere to Novartis and project specific standards Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regulatory guidelines)
Develops statistical analysis plans including analysis files and report specifications
Develops appropriate statistical methods for data analysis and ensures the accuracy and reproducibility of data sets and analyses of clinical trial or registry data by following relevant work practices and procedures
Working closely with mutli-disciplinary teams (epidemiologists, statisticians, other data analysts) to ensure a complete review of the data, providing a thorough understanding of statisical processes and issues that may arise in analysis
Develops statistical analysis plans for clinical trials or registry studies with fully documented table, listing, and
Collaborates with Statistical Programmers on summary and analysis of trial data
Works as a member of a team to design and/or review protocols, case report forms, and statistical analysis plans
Provide statistical input in the study design phase and analysis phase, in careful review of the end product, focusing on appropriateness of statistical methods and validity of conclusions
Plan the statistical analyses, programming and execution of the analyses, instructing and reviewing third party statistical planning and analysis work
Perform hands-on data analysis and modeling of obtained data to provide outputs that will guide in decision making through various stages of project

Biostatistician Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Biostatistician

List any licenses or certifications required by the position: SAS, CITI, WPP

Education for Biostatistician

Typically a job would require a certain level of education.

Employers hiring for the biostatistician job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Biostatistics, Statistics, Writing, Education, Epidemiology, Public Health, Graduate, Computer Science, Applied Mathematics, Communication

Skills for Biostatistician

Desired skills for biostatistician include:

SAS computing package
Relevant Data Standards
Applicable clinical research regulatory requirements
SAS
Regulatory guidelines
Clinical trial design and analysis
Analysis
R
Statistical design
Programming techniques utilized in clinical research and to effectively communicate statistical concepts

Desired experience for biostatistician includes:

Preferred, Ph.D
Experience with intercultural teams
Understanding of clinical trial design and epidemiologic research methods
Possess an advanced degree in biostatistics, statistics, or a related discipline (Ph.D
Master’s degree in Statistics with 5+ years of relevant experience
Knowledge of statistical software packages

Biostatistician Examples

1

Biostatistician Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of biostatistician. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for biostatistician
  • Working on protocols, statistical analysis plans (SAPs), CRF design, and study initiations
  • Supporting statistical activities for Phase III program from study design, protocol development, SAP development, study initiation, validating analysis data sets and TLGs
  • Perform SAS programming to meet the needs of clinical trials as defined in the SAP
  • Works with the medical director, the regulatory lead and other clinical operations staff on the project team on clinical development plans
  • May participate on project teams as the lead biostatistician on multi-protocol projects within a therapeutic area
  • Communicates with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results
  • Design clinical studies
  • Write and review statistical sections and other relevant parts of study synopses and protocols
  • Support study start up activities
  • Develop RAP, program TLFs, preparation for database lock, dry run and CSR activities
Qualifications for biostatistician
  • Ability to promote teamwork in a multi-disciplinary team setting
  • Coordinate study tasks with other statisticians and other line functions
  • Ensure timeliness and adequate quality of statistical deliverables
  • Providing consultation on statistical methods
  • Master’s degree in statistics, biostatistics public health or related field
  • Ensure timeliness and adequate quality of all bio statistical deliverables for the assigned trials
2

Biostatistician Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of biostatistician. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for biostatistician
  • Propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
  • Write and execute SAS programs to analyze the data and to report results creating tables and standard listings
  • Perform statistical analysis, run simulations and discuss with internal and external experts
  • Process and adhere to company and project-specific standards
  • Reviews project protocols, authors protocol statistical
  • Reviews protocols and case report forms for soundness of trial design
  • Supports creation of publication material from a statistical perspective
  • Performs complex statistical analyses, interprets statistical results and helps prepare study reports including summaries for FDA submissions
  • Assists with clinical study design and protocol amendments
  • Performs relevant sample size calculations
Qualifications for biostatistician
  • Understanding of ICH GCP general knowledge of industry practices and standards
  • Interacts directly and independently with client to coordinate all facets of the project
  • Has high level knowledge of drug development as it pertains to biostatistics
  • Strong resource for biostatistics
  • Works with programming team to provide definitions, documentation, and review of derived variables needed to produce planned tables, listings, and graphs (TLGs)
  • Develops data and programming specifications jointly with programmers
3

Biostatistician Job Description

Job Description Example
Our company is growing rapidly and is hiring for a biostatistician. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for biostatistician
  • Knowledge and experience with CDC surveillance and case-control study design and analysis
  • Thorough understanding of statistical methods including, but not limited to, linear, logistic, and conditional logistic regression models, survey statistics and survival analysis
  • Authors or reviews statistical sections of clinical study reports
  • Writes complex statistical plans, protocols and reports
  • Provide statistical support to the CDC
  • Support statistical needs of Clinical Research and other project teams
  • Support clinical trial data management activities to include
  • Plan and execute a range of biostatistical activities to support Clinical Development and Medical Affairs
  • Oversee third party vendors as needed
  • Perform ad hoc analyses of existing databases, meta-analyses, and data mining
Qualifications for biostatistician
  • Assists in designing data presentations including summary tables, graphs, and subject listings
  • Monitors data quality from a study conduct and output perspective
  • Performs and/or coordinates and oversees the preparation, execution, reporting and documentation of all analyses (interim and final)
  • Assists in writing efficacy sections of clinical study reports and summary documents with in-house medical writers and the client's study team
  • Assumes responsibility for quality and statistical integrity of clinical study reports and summary documents
  • Performs analyses and prepares data presentations for clinical registration dossiers based on strategies developed by the client
4

Biostatistician Job Description

Job Description Example
Our growing company is hiring for a biostatistician. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for biostatistician
  • To develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
  • To do the QC of the statistical analysis methodology
  • To validate study specific dataset & analysis pgm specification
  • To provide stat support to an independent analysis center
  • Ensure the study design, monitoring, analysis will bring scientific information
  • Develop and oversee complex statistical functions including the design and analysis of pre-clinical experiments, clinical trials, outcomes research, grant preparation, authoring scientific and clinical publications, and implementing complex statistical methodologies
  • Be responsible for performing and interpreting statistical analysis on numerous clinical data sets, database management, and consultation on research
  • Evaluate databases and statistical analysis programs and interact with computer groups to determine hardware/software compatibility
  • Contribute to content and review of presentations and manuscripts
  • Provide statistical support for the Diabetes area
Qualifications for biostatistician
  • Conducts thorough self-reviews of own analyses prior to release to client
  • Follows processes related to project management as appropriate for biostatistical projects
  • Takes initiative to suggest and implement departmental process improvements
  • Leads some projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
  • Complies with Document Control Procedure
  • Complies with Record Control Procedure
5

Biostatistician Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of biostatistician. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for biostatistician
  • Provide statistical collaboration and/or consultation to research scientists, investigators, database designers, and managers of WRAIR/NMRC and outside clients
  • Assist in the development of formal experimental protocols subject to the Army, Navy, and Animal Welfare Regulations
  • Assist in the development of the statistical portion of human protocols
  • Apply a variety of biostatistical methods and tools
  • Document critical reviews at an appropriate level for the intended audience
  • Status report meeting with COR will occur on a weekly basis with Tuesday as the targeted day
  • Products provided to the customers shall be free of obvious errors and consistent with statistical methods published in peer reviewed literatures
  • Preparation of sections of statistical reports, input into Clinical Study Reports, under the supervision of senior statistical staff
  • Display interpersonal and effective communication skills
  • Be responsible for the statistical designs of clinical/epidemiological studies, creating statistical sections for study synopses and protocols
Qualifications for biostatistician
  • Ensures compliance to applicable ISMS policies and procedures
  • Oversees data management (auditing, editing & analysis) and quality control of study databases
  • Participates in project development from beginning to end
  • Work will be performed in an office environment with a low to moderate noise level
  • Candidates must be a US citizen or permanent resident
  • Candidates must be able to pass a Minimum Background Investigation

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