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Biostatistician Resume Sample

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❶Familiarity with SAS and R to manage and analyze data Ability to create interactive web applications Ability to write comprehensive technical reports and scholarly articles Excellent organizational and interpersonal skills Demonstrated ability to work effectively with faculty, students, and others. Designed and composed clinical protocol, case report forms, and statistical plan for investigational device exemption IDE trial.

Senior Clinical Research Associate/biostatistician

Principal Statistician - Office of The Inspector General
Biostatistician-ii
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May advise on validation checks Assist project lead in fulfilling project responsibilities Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for single studies. Perform duties of a Trial Statistician to support regular clinical trials within national or international development projects or for marketed products as required. Collaborate with Trial Clinical Monitor and trial teams incl. Support Project Statisticians 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 Plan valid, efficient and cost effective clinical trials, typically based on outlines provided by Project Statisticians.

Support other Trial Statisticians in their responsibilities Prepare accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications. Support other Trial Statisticians in their responsibilities.

Support other Trial Statisticians in their responsibilities Review and evaluate proposed case report forms for consistency with information needs for the protocol Review randomization to be used in the clinical trials. Performs statistical analysis for pre-clinical, clinical, and post-marketing projects in support of product development and U. Participates as a highly valued member of core teams for Phase II and III stages, clinical sub-teams, and core teams Acts as liaison on behalf of department with internal personnel and outside customer representatives at various levels concerning processes or scheduling of specific phases of projects or contracts May supervise other Biostatistics staff Ph.

Implement different statistical methods to identify significant associations, including both parametric and non-parametric methods e. RNA-seq, ChIP-seq, bisulfite sequencing Create and maintain simple databases for data management Create graphs and data visualization strategies that enable better experiment interpretation Assist researchers with power calculations and experiment design Communicate results and assumptions of analyses in written and oral summaries.

Provides statistical analysis programming, including completion of basic descriptive and inferential analyses and the interpretation of results Reviews data for discrepancies, interact with data managers, and create analysis datasets Presents interim and final results, including tables and figures, and provide a written description of methods and statistical analyses used Conforms to statistical programming and analysis standards Must be able to perform the essential functions of the Biostatistician I Employees in this position work on multiple tasks simultaneously and, as such, may have competing deadlines or time constraints, which may require consultation with their supervisor to prioritize responsibilities.

Proficient in Perl, Python, or other scripting languages for data munging Skills in statistical estimation, statistical inference, and modeling fitting diagnostics Proficient in R or SAS Knowledge of non-parametric statistics, Bayesian methods, and small sample size methods 2 year of experience doing collaborative biostatistics 2 years of experience manipulating large databases programmatically Previous experience in an academic institution, or academic hospital setting Master's degree in biostatistics, statistics or related field Ability to work independently and collaboratively 1 year of experience doing collaborative biostatistics.

Must be self driven and able to communicate effectively with collaborators in medicine and biology The position will require frequent interactions with others in all phases from experimental design to paper submission.

As such, exceptional written and oral communication skills are required Time management skills are necessary, as there will be multiple active projects at any given time. May involve designing or enhancing data storage system Train staff on trial and project level activities and internal processes Good understanding of global clinical trial practices, procedures and methodologies Good understanding of regulatory requirement relevant to Biomarker Development e.

SAS, python, SQL, R Experience in providing recommendations for maintenance or development of global policies, procedures and clinical data presentation standards Good organizational, presentation and project management skills; ability to work under pressure and meet timelines Strong interpersonal and communication skills; ability to work as part of an international team without close supervision. Interact with scientists performing the assays and the DHVI statistical core to further develop processes and tools for optimal data analysis of large high content data sets Oversee the use of the custom tools.

Evaluate system problems, develop and implement corrective action plans Develop and implement systems for data quality control. Implement performance metrics for measuring workflow efficiency and generate work flow analysis on a per-study and per-technician basis. Create binding antibody data sets from these data in conjunction with the appropriate oversight groups e. Assist with the implementation of new data queries as requested Collaborate with the DHVI statistical programming unit to analyze large data sets.

Provide feedback to the statistical programming unit and to the investigators or program management as appropriate to refine queries and analyses, developing reports on new data queries as appropriate Provide data summary and analysis reports including both data and text summaries.

Work with the DHVI statistical core to mine clinical information databases Initial laboratory training will be provided on scientific laboratory methods for the evaluation of antibody responses for educational purposes to provide an overview of the work Work with the laboratory PI, statistical team and laboratory staff to perform additional duties as needed for the completion and evaluation of antibody responses Perform any other data management or statistical tasks deemed necessary by the Director for completion of projects.

Leading statistical analyses to support scientific and medical publications, as well as public presentations, in collaboration with a global publication team including external scientific leaders, clinicians, medical writers, and marketing representatives Providing expert input into clinical trial data interpretation and presentation which may include data from oncology trials with novel designs Providing technical direction to statistical programming in analyzing clinical trial data, and coordinating the statistical activities for publications Solid knowledge of statistical analysis methodologies and clinical trial designs Strong presentation and written communication skills.

Able to function effectively in a team environment An understanding of biology of disease and drug discovery and development in a variety of therapeutic areas. Leading a project team. This involves conducting team meetings, maintaining project timelines, assessing resources needed, providing resources, and preparing the budget. Ensure that Standard Operating Procedures are being followed and that appropriate project documentation is ongoing Coordinate with programmers and data management personnel as to database maintenance, updating and documentation.

To perform duties of a Trial Statistician to support clinical trials within national, regional or international development projects or for marketed products as required. Familiarity with SAS and R to manage and analyze data Ability to create interactive web applications Ability to write comprehensive technical reports and scholarly articles Excellent organizational and interpersonal skills Demonstrated ability to work effectively with faculty, students, and others.

Draft or review protocol and statistical analysis plan for HEOR studies including post-hoc RCT analysis, network meta-analysis or indirect treatment comparison Prepare, verify, and manage research data sets as per provided specifications Conduct analytic quality assurance procedures and ensure quality of final deliveries Solid background on statistical modeling methods and simulation Experience with conducting HEOR or RCT studies Ability to work independently under general guidance Strong hands on experience with standard software package as SAS, knowledge of R, OpenBUGS, or other analytic packages a plus.

Utilize research methodology and data collection tools to ensure that appropriate data are gathered Assist in planning statistical study design for planned projects Conduct data analyses including but not limited to descriptive statistics, factor analyses, generalized linear models, random effects models, analysis of survey data, and other statistical methods Manipulate and extract data from appropriate sources, including Emerging Infections Program databases in.

Creates analysis datasets and associated dataset specifications; reviews data for discrepancies and works with the study team to resolve discrepancies Prepares and presents interim and final study results e. This includes reviewing study materials prepared by other team members With direction from supervising statistician, coordinates study statistical team to support project needs.

This includes completing quality assurance procedures, ensuring statistical documentation is current, and archiving materials for completed deliverables In consultation with supervising statistician, successfully negotiates timelines and manages competing deadlines Recognizes potential areas of concern related to study design, statistical, or data issues.

Works to understand issues, identifies potential solutions, and consults with supervising or faculty statistician Actively expands own knowledge and understanding of statistical methods and programming Conforms to statistical and shared data coordinating center working guidelines and standard operating procedures With direction from supervising or faculty statistician, assists in the preparation of abstracts, presentations and manuscripts; includes drafting analysis plans With direction from supervising or faculty statistician, communicates with study investigators and other clinicians regarding statistical issues, analysis planning, study results, and the interpretation of study results.

Previous experience in oncology is required Master degree or higher in statistics or related field Efficacious SAS programming skills. Contractor shall provide expert consultation in the development of a statistical analysis plan SAP to meet the objectives of the protocol Apply a variety of biostatistical methods and tools.

Expected application areas include analysis of variance, survival analysis, logistic regression , generalized linear mixed-effects models and construction of graphical displays for statistical visualization Perform SAS programming to meet the needs of clinical trials as defined in the SAP.

Contractor will develop data display shells and mock tables, listings and figures to test the system prior to implementation. Contractor shall prepare and present final tables, listing and figures to investigators. Contractor shall maintain records and version control for program Provide clear oral or written advice with regard to statistical procedures Provide hands-on training on how to use statistical software's for all or some of the following: Reviews are conducted for manuscripts and publications written by others with regard to good statistical practices With the approval of the COR, the employee may be given time and encouraged to review relevant statistical literature and adapt statistical methods as necessary Shall internally document assumptions, data sources, databases, procedures, statistical analyses, and computer programming code so that results can be replicated even if the originating staff member is no longer available.

Data sets, analysis software, and documentation shall be in digital format, accessible to the COR, and shall be provided to the COR upon expiration of the contract Status report meeting with COR will occur on a weekly basis with Tuesday as the targeted day.

In all cases, reports, statistical algorithms, computer programs and data used to generate results shall be provided in digital formats Shall provide weekly status reports delivered to the COR by COB on the last day of the month including the following: StatXact, Nquery and understanding of database structures Serve as lead statistician on selected multiple projects. Learn and follow departmental procedures for statistical analyses and programming work Serve as a lead statistician on large and complex projects Lead a project team.

This involves conducting team meetings, maintaining project timelines, assessing resource needs, providing resources, and budget preparation. Ensure that SOPs are being followed and that appropriate project documentation is ongoing. Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Also contribute to writing appropriate protocol sections Provide randomization schemes and appropriate documentation.

Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming.

Define appropriate methods and procedures for statistical analysis. Develop or supervise creation of table and listing specifications. Ensure that proper validation for statistical tables and listings is being implemented Perform statistical analysis for key efficacy endpoints Prepare reports, manuscripts, and other documents. Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed Communicate with sponsors concerning project workscope and budgetary changes after reviewing with management Providing administrative support Mentor other members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning Act as the representative of the department to other divisions Provide general infrastructure support to the Biostatistics Department.

Assist in bidding and business development activities. Consult with business development with respect to bids and timelines PhD degree is desirable. Understanding of the FDA, ICH, CDISC, and other applicable Guidelines related to the conduct of compliant clinical trials Good understanding of basic statistical procedures and statistical methodology Experience in SAS programming, including understanding of macros Excellent organizational skills, written and verbal communication skills, and working knowledge of Microsoft Office Suite is a must.

Content expertise in any of the following areas of health care: Shows an active participation toward learning new statistical concepts, and the relevant aspects of the disease area of the related clinical programs Provides examples of being a self-starter who is self-directed and self-motivated without putting self first Able to adapt to working in a multicultural global environment. This position will become an expert user of Tableau software. This position will generate reports and interactive dashboards allowing users to evaluate specific areas of interest and conduct exploratory analyses using developed tools Training with State EMS Data Managers and Local EMS Providers.

This position will offer webinar training sessions to familiarize potential users with available interactive reports. Interprets and presents results along with an explanation of techniques used in written forms including memoranda and reports, abstracts for presentation and manuscripts for publication At least three years of relevant statistical experience in medical environment.

Design clinical trials and provide sound statistical guidance on clinical development project Provide sample size estimates for proposed studies Oversee and monitor CRO performance on implementation of SAP Write statistical section of study protocols, statistical analysis plans and study reports Review and consult on CRF design Develop clinical trial randomization Review study protocols, CRFs, database structures, edit check specifications, analysis plans, study reports and annual reports Lead study or project team in the review and discussion of SAP Maintain study documentation of statistical analyses and supportive documents.

Consult with research investigators on research projects. Must be able to work on multiple tasks simultaneously and, as such, may have competing deadlines or time constraints Assists in the preparation and submission of abstracts and manuscripts Participates in grant preparation.

Direct exploratory analyses to discover or define possible drug effects or claims Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management.

From a statistical perspective, is the primary contact for CROs programming validation 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 Ensures efficient work within the team by setting priorities and avoiding overlaps between team members Ensures good communication between team members.

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 Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management.

Good knowledge in applied statistics and data analysis methodology including categorical data analysis, survival analysis, etc Appreciation of clinical research and drug development process Appreciation of ICH guidelines, regulatory requirements and industry standards e. Preparation and review of Statistical Analysis Plans and Statistical Contributions, under the direction of senior Statistical staff Statistical analysis of clinical trial data using basic methodology, under the direction of senior Statistical staff Production of data tables and graphs to the required specification for clinical, pharmacokinetic and statistics reports Generation of randomization schedules from provided specifications May review the format of CRFs under the direction of senior Statistical staff Perform sample size calculations as required Maintain project administration files with regard to all documents produced by Biostatistics, including associated review, QC and project tracking information and internal and external communications Provide statistical support to SAS Programmers Scheduling of clinical statistical work to meet required deadlines.

Ensuring that projects are completed in a timely and accurate manner Liaison with internal and external clients, as required, with regards to the requirements for analysis, tables and graphs Review of Clinical Study Reports May authorize final reports as one of the Covance signatories May perform QC of data displays for secondary efficacy and safety variables Display interpersonal and effective communication skills. Co-operative and team orientated Promoting a professional attitude at all times both internally and externally and dressing accordingly in an appropriate manner Performs any other duties as assigned.

Co-operative and team orientated Training of other members of staff within the department in statistical methods and programming techniques Related experience or PhD degree in Statistics considered in lieu of experience Skilled in the use of PC based statistical packages e. SAS and general computer operation Programming experience is beneficial. Assist with the design and analysis of medical device clinical trials in humans Perform statistical analysis and validate as defined in analysis plan Assist with preparation of analyses that support Regulatory submissions for product approval Provide under detailed supervision statistical support for peer-reviewed journal publications Deliver results in a manner that is time-sensitive, high quality, proactive and communicative with collaborating entities and Stakeholders Perform sample size and power calculations Assist in review of CRFs and edit checks Review and understand analysis plans Write interpretation of results with oversight from supervisor Work with data Management partners to organize timely and accurate data extraction from EDC or other system into statistical programs for analysis.

Strong applied statistics background Past experience as a clinical trials statistician preferred, although experience in a research environment would be considered Strong SAS programming skills in a clinical data environment.

Uses data science to synthesize unstructured, disjointed information into meaningful, compelling narratives that facilitate development and refinement of health system strategy Supports requests from health system entities by identifying potential data sources, gathering data, conducting statistical work and communicating findings and implications Supports the collection of national, regional, and local data for benchmarking and comparative analytics Keeps abreast of developments and changing technologies and applications via self- initiated professional development.

Participates in continuing education courses, professional organizations, attends training and trade seminars, and maintains professional contacts in the community and the industry. Provide data analysis support for researchers and biostatisticians in the research department by using statistical software Produce tables and graphics for statistical reports using a SAS and other computer languages Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation Assist with interpretation of analysis results Design and implement appropriate data collection and quality control methods Minimum one 1 year of experience in analyzing research data using statistical package s Experience with medical or health research Minimum one 1 year of related statistical consulting experience in healthcare or medical research areas Knowledge and experience with SAS programming language Experience in asthma research preferred Fast learner, detail oriented, and a good communicator Intellectual curiousity.

Interact with Regulatory and Safety to define statistical content of complex documents Support to key business projects, e. Performs statistical analysis for pre-clinical,clinical, and post-marketing projects in support of product development and U.

Assist with protocol development, sample size calculation, protocol and case report form CRF review Under supervision, act as statistical team lead for single studies PhD in biostatistics or related field; Master's degree in biostatistics or related field and 1 year relevant experience; or equivalent combination of education, training and experience.

Provide statistical input into Data Monitoring Committee DMC activities, including development of DMC charters and analysis plans Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis Good analytical skills and project management skills Prior experience with SAS programming require.

Using statistical software to program basic and advanced statistical analyses Data cleaning and management Assistance in writing up results for presentation and publication Meeting with investigators and multidisciplanary teams to review and advise on statistical analyses Assisting the BECS on administrative matters, including coordination with other statisticians and investigators.

Investigators and other members of the internal and external research group Detail and process oriented Ability to manage multiple projects simultaneously, including both long-term and short-term projects Ability to make decisions related to issues in the statistical group pending final approval from the Director Demonstrated sound independent judgment and competencies in clinical research.

Provides basic statistical analysis support Reviews data for discrepancies, interacts with data managers, and creates analysis datasets Prepares and communicates statistical results in written and oral summary Works collaboratively with supervising and other statisticians in supporting project needs.

MS with 8 years or PhD with 6 years working in applied statistics, including publications Ability to handle a large volume of highly complex tasks with little to no supervision Proficiency and experience in SAS programming, and detailed knowledge of SAS procedures and other statistical software Effective team player: Degrees in such disciplines as statistics, economics, or mathematics are the normal requirement for a Statistician's resume, though experience in operational research, medical or life sciences, or business studies are also acceptable.

For more information on what it takes to be a Statistician, check out our complete Statistician Job Description. Looking for cover letter ideas? See our sample Statistician Cover Letter. Want x more interviews guaranteed? Provided statistical expertise on over one hundred key audits, as well as the design and execution of internal surveys. Analyzed statistical data of missile and ordinance systems to establish reliability estimates, the existence of component degradation, and calculate parameters for modeling the expected service life the item.

Responsible for all statistical analyses in support of digital marketing, including development of targeting equations, e-mail list segmentation and data mining using SAS, SQL, Omniture Site Catalyst, Lotame and Hitwise.

Extracted, cleaned data and merged working datasets in different formats; maintained and updated data. Performed regression analysis on component level testing data. Determined trends and presented findings to various levels of management. You are looking for your dream job and need a resume? My Perfect Resume is your solution and takes the hassle out of resume writing.

Use pre-written bullet points - Select from thousands of pre-written bullet points. Save your documents in pdf files - Instantly download in PDF format or share a custom link. Create a Resume in Minutes. Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems Provide update on program progress with focus on biometrics to management Design and write statistical analysis plans for clinical trials or oversee this work Knowledge of FDA regulations, ICH GCP guidelines, the drug development process Collaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designs Provide leadership to the biometrics team data management, programming, statistics on a given clinical program, group of programs, or key study ies ; review work of statisticians supporting this work Write statistical sections of regulatory submissions or oversee this work.

Provide fiscal oversight to project especially contract budgets. Solid knowledge of statistical analysis methodologies and experimental design Solid knowledge of statistical applications in pharmacoloepidemiology and safety evaluations Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions Solid record of leadership in professional society activities Solid knowledge of statistical and data processing software e.

Read our complete resume writing guides. Advise data management staff on database design, and critical data. May advise on validation checks Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for single studies. May manage project budget and resource requirements and provide revenue and resource forecasts for single studies Assist with review of RFPs and QIPs; prepare proposal text.

Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. Strong individual initiative Ability to provide and accept direction of lead team members PhD in biostatistics or related field; Master's degree in biostatistics or related field and 1 year relevant experience; Bachelor's degree in biostatistics or related field and 2 years relevant experience; or equivalent combination of education, training and experience.

Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims Writes data analysis plans as needed to capture design elements and statistical methodology Develops data entry spreadsheets as needed Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization Maintains expertise in state-of-the-art data manipulation and statistical analyses, and mentors less experienced colleagues Manages day-to-day operational aspects of a project.

Such other responsibilities and projects that the Company may assign Familiarity with later Phase studies, eg, non-interventional, retrospective studies, or experience working with Health Technology Assessment HTA bodies Able to serve as a senior statistical and pharmaceutical consultant for biostatisticians in GSS and across therapy areas Able to conduct independent statistical research Sound knowledge of the ICH guidelines.

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RESUME Chris Barker, Ph.D. Clinical Trial Biostatistician. ADDRESS. Home: Chestnut Street. One publication received a Public Health Service Award. Supervised and scheduled project Ph.D. Biostatistics. University of Illinois Health Sciences Center. Chicago, IL. About 10 years extensive experience in statistical analyses for clinical trials and drug development (pharmaceutical manufacturing). Clinical Trials experience of 4 to 5 years involving Phase I, II, and III.