A Biostatistician is a professional who uses statistical methods and data analysis to address problems in the field of biology and medicine. They perform data review and statistical analysis, write statistical analysis plans, and provide statistical support. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Biostatisticians.

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Main Responsibilities of Biostatistician

The following list describes the typical responsibilities of a Biostatistician:

Advise

Advise data management staff on database design, and critical data.

Align with

Align with data integrity standards and business ethics requirements.

Analyze

• Analyze clinical trial data producing accurate results representing the outcome of the trial.

• Analyze data from projects.

Anticipate

Anticipate and plans for mitigations for product, process, project, and schedule risks.

Approve

Approve protocol as signatory.

Assess

• Assess drug specification limits and process control limits.

• Assess feasibility of proposed work.

Assist in

• Assist in developing SDTM and ADaM mapping documents and datasets.

• Assist in performing / reviewing sample size calculations.

• Assist in performing statistical QC of final clinical study reports.

• Assist in the development of new statistical tools and modeling protocols.

• Assist the Head of Biostatistics when requested in any of their job responsibilities.

• Assist with in-house clinical assay validation.

• Assist with preparation of analyses that support Regulatory submissions for product approval.

Assure

Assure quality of personal work.

Author

• Author and drive procedures at a corporate level.

• Author and drive requirements definition at project / cross-functional level.

Build

Build predictive models for forecasting and interpretation of clinical studies.

Coach

Coach junior team members, particularly in software development.

Collaborate with

• Collaborate in the preparation and review of protocols, CRF design and clinical study reports.

• Collaborate in writing statistical sections for integrated reports or / and statistical reports.

• Collaborate on data management optimization to accommodate new data structures.

• Collaborate with medical leaders and principal investigators.

• Collaborate with the data and engineering team in systematising data processing models.

Communicate

• Communicate results verbally and in written reports to the investigator.

• Communicate with clients regarding study protocol or statistical analysis issues.

Conduct

• Conduct analytic quality assurance procedures.

• Conduct statistical analyses and interpret results of statistical analysis.

• Conduct user interviews and training sessions.

Consult

Consult and advise on multiple technical process, project, or investigation content.

Contribute to

• Contribute to operation process optimization and provide inputs to statistics standards.

• Contribute to proposal activities and client presentations.

• Contribute to review and amendment of departmental processes and supporting documentation.

Coordinate

Coordinate ADam mapping with Sr. Programmer when needed.

Create

• Create analysis datasets per specifications for each study.

• Create or reviews programming specifications for analysis datasets, tables, listings, and figures.

Defend

Defend results and analysis externally.

Define

Define the randomization procedures and producing randomizations lists.

Design

• Design analysis strategies for biological data, including repeated biomarker measurements over-time.

• Design and implement workflows using advanced bioinformatics and biostatistics.

• Design predictive modeling programming for evaluating health outcomes, utilization, and costs.

Determine

• Determine documentation requirements for Biostatistics aspects of projects.

• Determine proper summary statistics, report formats and address all other analysis considerations.

Develop

• Develop analysis plans, table shells, programming and table specifications.

• Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.

• Develop and / or review study progress, data, and safety monitoring plans, outcomes review plans.

• Develop and program PK statistical analysis.

• Develop randomization and sample size programs for clinical studies.

• Develop SAS macros, templates and utilities for data reporting and visualization.

• Develop statistical analysis plans.

• Develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications.

• Develop statistical aspects of study designs, study protocols and study proposals.

• Develop statistical programming and manage projects to meet deliverables and milestones.

• Develop statistical programs as necessary to perform analyses and prepare data displays.

Diagnose

Diagnose symptoms and gets to root cause.

Document

• Document and validate programs and files for analysis.

• Document methods, instructions and rules for implementing new techniques and research tools.

Draft

Draft presentations of statistical findings and methods.

Engage

Engage with lead investigators, research teams, and data warehouse experts.

Ensure

• Ensure all statistical methods comply with regulations, guidance and standards.

• Ensure scientific integrity and data quality of clinical trials are preserved.

• Ensure that methods and results are presented correctly.

• Ensure that project deliverables meet analysis and submission requirements.

Estimate

Estimate analytical measurement and manufacturing process variability s.

Execute

Execute on ongoing HTA evaluations, including analysis and interpretation of HTA results.

Follow

Follow best practices in programming documentation.

Generate

• Generate or perform QC on clinical trial patient randomization codes and treatment assignments.

• Generate or validates sample size / power calculations and randomization schemes.

• Generate randomization schedules from provided specifications.

Help

Help with writing grant proposals.

Identify

• Identify out of scope tasks and escalates to management.

• Identify and recommend solutions to data management issues.

Implement

Implement established statistical methods to analyze clinical data and interpret results.

Inspire

Inspire new ideas, innovation and challenges the status quo.

Interact with

• Interact with the sponsor on statistical aspects of the project and present at meetings as required.

• Interact with regulatory agencies and support sponsor in new drug application.

Interpret

• Interpret analyses and write statistical sections of study reports.

• Interpret statistical results.

Investigate

Investigate and implement new technologies, processes and procedures.

Keep

Keep up to date current on statistical methodology and computing development.

Lead

• Lead and drives innovation utilizing external information and ideas.

• Lead and provides statistical support to the cross-functional teams preparing HTA submissions.

• Lead project teams developing and modifying highly complex information solutions.

• Lead research activities for innovative statistical methods and applications in HTA activities.

• Lead rigorous logic, problem solving, and process improvement efforts.

Maintain

• Maintain data integrity and support data analysis as necessary.

• Maintain knowledge of the current regulations and technologies related to data management.

• Maintain the statistical integrity of clinical trials analyzed by SDC.

• Maintain up-to-date knowledge about analytical techniques.

Make

• Make recommendations and assist in data capture, data extraction and analysis.

• Make recommendations for appropriate statistical analyses and design to investigators and study team.

• Make decisions including architecture, resource, schedule, and cost estimates within unit of work.

Manage

Manage real world database operations, analytic programming and statistical modeling activities.

Mentor

• Mentor and guide junior staff.

• Mentor junior level Biostatisticians.

Operate

Operate both as a team and independently, with adaptability to changing requirements.

Oversee

• Oversee and maintain statistical programs for data collection, analysis, and reporting.

• Oversee data management and programming activities for assigned projects.

• Oversee the development of Data Management Plans (DMPs) for assigned projects.

Participate

• Participate and help with implementation of Frontier Science Boston statistical computing capacities.

• Participate in approved process improvement initiatives.

• Participate in business development and maintenance activities.

• Participate in developing and executing customer relationship management plans.

• Participate in interactions with regulatory agencies, as required.

• Participate in peer review and critique of reports and analyses from studies conducted by colleagues.

• Participate in presentations to regulatory reviewers.

• Participate in special initiatives requiring statistical input as appropriate.

• Participate in the development of SAS programs and macros utilities pertaining to clinical trials.

• Participate in the writing of trial protocols and research proposals.

Perform

• Perform analysis of external technologies and applies astute judgment to business opportunities.

• Perform data review and statistical analysis.

• Perform other miscellaneous activities as required.

• Perform other related duties incidental to the work described herein.

• Perform other work-related duties as assigned.

• Perform peer review of SAPs and other technical documents written by others.

• Perform programming of statistical analyses and study output.

• Perform quality control of analysis data and TLGs.

• Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets.

• Perform / review sample size calculations.

• Perform stability analysis of drug products, and estimate stability profiles and shelf lives.

• Perform statistical QC of final clinical study reports.

• Perform statistical queries, analyses, and evaluation as assigned through the Biostatistics Core.

• Perform the statistical analyses according to study protocol / SAP.

Plan

• Plan and analyze pilot data.

• Plan and carry out professional development.

Prepare

• Prepare manuscripts for publication.

• Prepare slide decks for congress or manuscript submissions or internal or external communications.

• Prepare Statistical Analysis Plans (SAP) and develops table shells and output specifications.

• Prepare statistical reports or statistical sections of clinical study reports.

• Prepare tables, charts, and graphs showing the results of statistical analysis.

Present

Present and share knowledge at team meetings and / or at monthly seminars.

Prioritize

Prioritize work and complete deliverables to timelines with minimal supervision.

Process

Process and assist in writing papers.

Produce

Produce high quality written documentation including study plans and reports.

Program

Program summary tables, data listings and graphical representations of clinical trials data.

Provide

• Provide data visualization templates for interface and documentation.

• Provide guidance to less experienced staff as needed.

• Provide input into data collection forms (Case Report Forms) and data management plan.

• Provide input to SOPs, test protocols, study reports, regulatory submissions and queries.

• Provide meaningful input to the development of a report strategy.

• Provide regular reports and presents analysis results to study team.

• Provide sound methodologic review to an internal scientific review panel.

• Provide statistical and data management input into protocol development.

• Provide statistical expertise for study design of clinical trial protocols.

• Provide statistical input for protocol and CRF development.

• Provide statistical input into design / review of format of CRFs.

• Provide statistical input to senior management.

• Provide statistical programming support as needed.

• Provide statistical representation on multi-disciplinary team preparing protocol.

• Provide statistical support for protocol development, grant application and scientific publication.

• Provide statistical support, including methods and interpretation of the statistical results.

• Provide statistical support to answer questions from external clients (such as FDA, Investigators).

• Provide support materials such as randomization lists, reliability assessment.

• Provide technical solutions and advice to staff and clients on statistical processes.

• Provide timely and scientifically sound statistical expertise to clinical development projects.

• Provide training, guidance and mentorship to lower level and new staff.

Recommend

Recommend quality control (QC) assay limits and evaluate assay performance.

Represent

• Represent Biostatistics on Project Teams.

• Represent the bioinformatics department and R&D function on project teams.

• Represent TFS Biometrics in sponsor and investigator meetings.

• Represent the department during project-driven client audits.

Research

Research and development of statistical methodologies.

Review

• Review and approve on SOPs, protocols and reports.

• Review and confirm ADaM dataset specifications.

• Review and provide input in interpreting analysis result to clinical study report.

• Review CRF and other study specific specifications and plans.

• Review CRFs, study protocol, and clinical study report.

• Review data to ensure consistent, accurate and valid conclusions.

• Review protocols for completeness, appropriateness of clinical design and sound statistical analysis.

• Review table shells for clinical study reports.

Specify

Specify randomization schedules and test their implementations.

Suggest

Suggest and implement changes in methodology based on output review.

Supply

Supply statistical input for regulatory submissions and in response to health authority questions.

Support

• Support and adheres to the Compliance Program, to include the Code of Ethics and Business Standards.

• Support investigations of deviations, and unusual and out of specification results.

• Support lead biostatistician on clinical studies.

• Support ongoing safety review of the program / study teams and data monitoring committees.

• Support the Population Medicine team with all data management and analyses.

• Support the programmers work and / or perform programming of statistical analysis and study output.

• Support the team with statistical analysis and use computer based models to answer their questions.

Train

• Train and supervise contract statisticians and ensures the quality of their deliverables.

• Train staff with varying degrees of knowledge to effectively use the database system.

Understand

Understand and apply business requirements and processes.

Use

Use project management skills to initiate, plan, execute, and control resources and timeframes.

Work with

• Work closely with IT team to translate models and algorithms into engineered production applications.

• Work closely with the data management team.

• Work with colleagues to plan and execute data analysis verification.

• Work with PK / Biostatistics team to prepare and review SOPs.

Write

• Write and execute computer analyses programs as required for the execution of analysis plans.

• Write guidance documents for regulatory submissions.

• Write interpretation of results with oversight from supervisor.

• Write / review the statistical analysis plan.

• Write statistical analysis plans.

• Write statistical sections of integrated reports.

• Write the statistical sections in the study protocol.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Biostatistician:

1. Statistics

2. SAS

3. Biostatistics

4. R

5. Pharmaceutical Industry

6. Clinical Trials

7. FDA

8. ICH

9. Analysis

10. CRO

11. Statistical Programming

12. Adam

13. Clinical Research

14. Drug Development

15. Pharmaceutical

16. Microsoft Office

17. Python

18. Statistical Analysis

19. SDTM

20. GCP

21. SQL

22. Data Management

23. Graph

24. Regulatory Guidelines

25. Clinical Trial Design

26. Clinical Concepts

27. Clinical Development

28. Data Processing Software

Most In-demand Soft Skills

The following list describes the most required soft skills of a Biostatistician:

1. Written and oral communication skills

2. Interpersonal skills

3. Organizational capacity

4. Time-management

5. Attention to detail

6. Work independently with little direction

7. Analytical ability

8. Multi-task

9. Collaborative

10. Initiative

11. Communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues

12. Leadership

13. Present problems

14. Team player

15. Presentation