Main Responsibilities and Required Skills for Statistician
A Statistician is responsible for performing statistical analysis and data review. They collect and prepare appropriate data, conduct complex data analysis, and interpret statistical results. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Statisticians.
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Main Responsibilities of Statistician
The following list describes the typical responsibilities of a Statistician:
Advise
Advise data management staff on database design, and critical data.
Apply
Apply a complete understanding of theories and principles to biologics development.
Apply existing statistical methods or develop new ones to address scientific problems.
Assist with
Assist peers to develop efficient designs, protocols, and reports per agreed timelines.
Assist with drug formulation and development.
Assist with preparation of analyses that support Regulatory submissions for product approval.
Assist with the design and analysis of medical device clinical trials in humans.
Assist with the design of research protocols including sample size calculations and randomization.
Attend
Attend bid defense meetings face-to face or via webex.
Attend team meetings regularly.
Build
Build predictive models for forecasting and interpretation of clinical studies.
Build relationships with Federal and commercial clients.
Collaborate with
Collaborate in writing statistical sections for integrated reports or / and statistical reports.
Collaborate with data and engineering team in productionise models.
Collaborate with medical leaders and principal investigators.
Collaborate with the data and engineering team in systematising data processing models.
Communicate
Communicate and explain to scientists the statistical conclusions of the analyzes.
Communicate progress of data collection operations to management and staff.
Communicate statistical concepts and results to a diverse audience.
Communicate study results and statistical concepts in internal and external meetings.
Compile
Compile reports, charts, and tables based on established statistical methods.
Conduct
Conduct complex data analysis such as Bayesian and Non-Linear Mixed Models.
Conduct data checks to ensure data integrity.
Consult
Consult and advise on multiple technical process, project, or investigation content.
Contact
Contact health / regulatory authorities regarding statistical issues when needed.
Contact with client across multiple disciplines.
Contribute to
Contribute to / advise on feasibility assessments of proposed study designs and analysis plans.
Contribute to and support development of competitive proposals and other technical writing products.
Contribute to define and review the specific deliverables related to Transparency and Disclosure.
Contribute to process improvement and departmental initiatives.
Contribute to the development of best practice to improve quality, efficiency and effectiveness.
Contribute to the development of standard operating procedures for clinical trials.
Contribute to the statistical methods section and verify for completeness and consistency for report.
Coordinate
Coordinate ADaM mapping with the senior programmer when needed.
Coordinate with other members of project teams throughout the company.
Create
Create analytical presentations, reports and dashboards.
Create or reviews programming specifications for analysis datasets, tables, listings, and figures.
Define
Define Biomarker Statistical Analyses Plans using state-of-the-art methodology.
Define randomization procedures and producing randomizations lists.
Demonstrate
Demonstrate good programming practices through proper documentation and commenting.
Design
Design analysis strategies for biological data, including repeated biomarker measurements over-time.
Design analytic approaches consistent with research objectives.
Design and implement workflows using advanced bioinformatics and biostatistics.
Develop
Develop advanced concepts, techniques, and standards.
Develop analytical reports to support ICHA's Population Medicine mandate.
Develop and deliver data science courses to nonclinical audiences.
Develop and / or review study progress, data, and safety monitoring plans, outcomes review plans.
Develop and program PK statistical analysis.
Develop effective collaborations with relevant non-statistical researchers.
Develop, provides and supports capability building on statistics within the network.
Develop standard data quality review checks and validation procedures.
Develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications.
Develop statistical aspects of study designs, study protocols and study proposals.
Develop statistical modules and provide formal training to statisticians and non-statisticians.
Develop statistical protocols and data analysis plans.
Develop visualizations and tools for understanding data and optimization.
Discuss
Discuss study conduct and results with physicians and sponsors.
Draft
Draft presentations of statistical findings and methods.
Encourage
Encourage boundary breaking by challenging colleagues to question established work processes.
Engage
Engage with lead investigators, research teams, and data warehouse experts.
Ensure
Ensure all statistical methods comply with regulations, guidance and standards.
Ensure all statistical work is processed on time to appropriate quality levels.
Ensure data completeness, quality and confidentiality.
Ensure efficient planning, execution and reporting of clinical studies.
Explain
Explain complex concepts to wide range of audiences.
File
File / archive essential documents.
Formulate
Formulate and modify innovative modeling and statistical techniques.
Generate
Generate or perform QC on clinical trial patient randomization codes and treatment assignments.
Generate or validate table programs.
Generate randomization schedules using SAS or randomization-specific software.
Help
Help with writing grant proposals.
Implement
Implement and test algorithms and techniques relevant to achieving project objectives.
Import
Import, clean, and transform data for sampling and weighting.
Inform
Inform supervisor or manager on important issues in a timely manner.
Interact with
Interact effectively with support staff (e.g., programmers and technical support specialists).
Interact with regulatory agencies and support sponsor in new drug application.
Interpret
Interpret statistical results.
Keep up to date on
Keep up to date on statistical methodology and computing development.
Lead
Lead and organizes review meetings.
Lead development and implementation of applications of advanced, innovative statistical methods.
Lead / participate in internal working groups and provide training in related areas.
Lead special assignments within biostatistics including development of work instructions and SOPs.
Lead statistical analysis.
Lead Statistician, Process Development.
Lead the Biostatistics portion of clinical studies.
Lead the validation of new macros.
Lead with Integrity and Respect.
Maintain
Maintain current knowledge in developments in statistical programming languages (SAS).
Maintain knowledge of the current regulations and technologies related to data management.
Maintain professional knowledge and expertise.
Maintain the statistical integrity of clinical trials analyzed by SDC.
Maintain the statistical integrity of the clinical trials developed by SDC.
Make
Make recommendations and assist in data capture, data extraction and analysis.
Manage
Manage clinical data to ensure security and confidentiality.
Manipulate
Manipulate and challenge data and processes to drive improvements.
Mentor
Mentor and guide junior staff.
Optimize
Optimize and tune algorithms for running in the cloud.
Oversee
Oversee the production of tables, listings, and figures.
Participate
Participate and help with implementation of Frontier Science Boston statistical computing capacities.
Participate in approved process improvement initiatives.
Participate in developing and executing customer relationship management plans.
Participate in developing detailed statistical analysis plans.
Participate in document review.
Participate in presentations to regulatory reviewers.
Participate in the development and maintenance of, and adhere to divisional SOPs and guidelines.
Participate in the writing of trial protocols and research proposals.
Perform
Perform ad-hoc and exploratory statistical analyses as needed.
Perform data review and statistical analysis.
Perform literature reviews and abstract relevant data.
Perform literature reviews to understand current approaches and implement new approaches.
Perform peer review of SAPs and other technical documents written by others.
Perform quality control checks of SAS code and output produced by Statistical Programmers.
Perform review on the SAPs written by others.
Perform sample size calculations and power analysis.
Perform statistical analysis and validate as defined in analysis plan.
Perform statistical QC of final clinical study reports.
Plan
Plan and organize project assignments of modest variety and complexity.
Prepare
Prepare for data reviews throughout the study.
Prepare periodic and ad hoc data status reports.
Prepare slide decks for congress or manuscript submissions or internal or external communications.
Prepare statistical analysis plan.
Prepare statistical reports or statistical sections of clinical study reports.
Present
Present findings at internal meetings.
Present statistical concepts and arguments to management, regulatory agencies and scientists.
Produce
Produce / review statistical reports.
Produce sample size calculations.
Produce standard error analysis routines and protocols (missing data & data errors checks).
Program
Program and analyze data sets using Python.
Program summary tables, data listings and graphical representations of clinical trials data.
Provide
Provide appropriate statistical input into study design and data analysis.
Provide data visualization templates for interface and documentation.
Provide expert knowledge and experience of complex trials design across different therapeutic areas.
Provide guidance and SASÒ code trouble-shooting to less experienced statistical analysts.
Provide guidance and training to less experienced staff as needed.
Provide independent review of project work produced by other biostatisticians in the department.
Provide input on standardization of processes, programs and documentation to improve efficiencies.
Provide meaningful and timely input in the development of a clinical program strategy.
Provide meaningful input to the development of a report strategy.
Provide mentorship to new or inexperienced research staff.
Provide sample size calculations.
Provide statistical and data management input into protocol development.
Provide statistical expertise to support clinical development objectives and strategy.
Provide statistical input to senior management.
Provide statistical programing support for assigned clinical studies or projects.
Provide statistical representation on multi-disciplinary team preparing protocol.
Provide statistical support for protocol development, grant application and scientific publication.
Provide support to across various therapeutic areas to senior statistical scientists.
Provide technical guidance to junior staff.
Provide training and guidance to lower level and new staff.
Provide under detailed supervision statistical support for peer-reviewed journal publications.
Recommend
Recommend environmental monitoring limits and rules.
Recommend revisions and modifications as needed.
Represent
Represent organization as the primary statistical contact on projects.
Represent statistics in regulatory meetings for biomarker topics.
Represent
Represent the department during audits.
Review
Review and Approves of procedures for assigned unit of work.
Review and examine statistical data distributions / properties.
Review and understand analysis plans.
Review CRFs, study protocol, and clinical study report.
Review protocols for completeness, appropriateness of clinical design and sound statistical analysis.
Review protocols to ensure statistical integrity and optimal study designs.
Suggest
Suggest and implement corrective action.
Suggest optimal statistical designs and methods that are acceptable to regulatory authorities.
Support
Support and adhere 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 one or several early phase studies in Onco early development.
Support on-going manufacturing, stability and product performance monitoring.
Support the design of sampling approaches that balance precision and cost.
Support the development of KPI's, their measurement and the maintenance of their data collection.
Support with statistical knowledge the implementation of standard tools for data analyses.
Understand
Understand and apply business requirements and processes.
Use
Use a number of data visualisation tools to render your analyses.
Use project management skills to initiate, plan, execute, and control resources and timeframes.
Work
Work as a leader in statistical related projects.
Work closely with external experts and suppliers in the mathematical modelling field.
Work collaboratively with multiple stake holders to develop scientifically appropriate strategies.
Work schedule assignments can be evenings and weekends as required.
Work well in a team environment and consistently follows standard operational practices.
Work with project team to decide on appropriate study design and statistical methodology.
Work with researchers to shape and direct research questions.
Write
Write and executes program verification plans.
Write compelling data driven presentations.
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 Analysis Plans (SAPs) for assigned projects.
Write statistical sections of protocols.
Write the statistical sections in the study protocol.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Statistician:
Analysis
Clinical Trials
Pharmaceutical Industry
Epidemiology
SQL
Statistical Programming
JMP
Data Analysis
ICH
Adam
Clinical Affairs
CRO
Most In-demand Soft Skills
The following list describes the most required soft skills of a Statistician:
Written and oral communication skills
Interpersonal skills
Organizational capacity
Attention to detail
Time-management
Problem-solving attitude
Analytical ability
Work independently with little direction
Leadership
Flexible
Multi-task
Collaborative
Initiative
Presentation
Critical thinker
