Biostatistician Senior Job Description
Biostatistician senior
provides statistical expertise for clinical validation studies to achieve regulatory approval of IVD and CDx assays in the US and internationally (including FDA PMA and equivalent EU approval).
Biostatistician Senior Duties & Responsibilities
To write an effective biostatistician senior job description, begin by listing detailed duties, responsibilities and expectations. We have included biostatistician senior job description templates that you can modify and use.
Sample responsibilities for this position include:
Understands and has the ability to use advanced statistical methods with some guidance
Leads the analysis and reporting of results for clinical trials program or registry database, which may include annual reports and/or other regulatory documents
Support (with review) trial planning and analysis activities in support of clinical trials, regulatory approval, and marketing efforts
Assist in preparing development programs for new drug indications
Provide primary statistical input for clinical study design
Provide analysis planning for clinical studies
Provide statistical input to clinical study reports to other disciplines related to clinical statistics
Be involved in communication with SAS programming, clinical data management, clinical trials management, regulatory affairs, clinical communications, clinical pharmacology, medical writing, and quality management
Manage data obtained from administrative databases, surveys, and other data sources
Conduct analysis of existing data, including VA and non-VA medical system administrative databases, vital and health statistics, cross- sectional surveys, retrospective and prospective cohort studies, and case-control studies
Biostatistician Senior Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Biostatistician Senior
List any licenses or certifications required by the position: SAS
Education for Biostatistician Senior
Typically a job would require a certain level of education.
Employers hiring for the biostatistician senior 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, Education, Medical, Communication, Technical, Computer Science, Epidemiology, Mathematics, Healthcare
Skills for Biostatistician Senior
Desired skills for biostatistician senior include:
Clinical practice
Resilience/prevention research
Significant developments and trends in military medical issues
Training for military service members
Agreement rates
FDA guidelines for in vitro diagnostic devices and the statistical basis for sensitivity
R
Reproducibility testing for validation and FDA clearance and approval
Specificity
/familiarity with national standards for quality
Desired experience for biostatistician senior includes:
Format data as needed for statistical analysis
Provides data summaries, analyses, and interprets results
Prepares data tables for presentation
Provides technical consultation for grant applications, including but not limited to assistance with power and sample size calculations
Performs statistical analysis and interpretation of data for projects and research grants
Develops statistical programs for data manipulation and implementation of standard and advanced statistical methodology
Biostatistician Senior Examples
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Biostatistician Senior Job Description
Job Description Example
Our company is growing rapidly and is hiring for a biostatistician senior. 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 senior
- Effectively interacts and presents results to investigators
- May assist and train users on computer programs
- Work with large clinical registry databases to construct patient cohorts and analyze data for comparative effectiveness and epidemiologic research
- Conduct statistical analysis, assist in developing study designs, communicate findings, and assist with preparation of manuscripts for publication in academic journals
- Meet regularly with investigators and under the supervision of a PhD-level methodologist to discuss research findings
- Attend and participate in regular research conferences
- Learn new skills and analytic techniques as needed
- Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking
- Develop statistical analysis plan
- Support other Trial Statisticians in their responsibilities
Qualifications for biostatistician senior
- PhD in biostatistics or related field and 1 year relevant experience
- Plan valid, efficient and cost effective clinical trials, typically based on outlines provided by Project Statisticians
- Prepare accurate, high quality reports of clinical trials for registration of drugs and biologics, and publications
- Prepare specifications for data analyses by outside vendors as required
- Designing, conducting, analyzing and/or presenting routine trials/studies
- Working with a team to apply statistical methodology to a research question
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Biostatistician Senior Job Description
Job Description Example
Our company is growing rapidly and is hiring for a biostatistician senior. 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 senior
- In the role as project leader, conducts briefings and participates in technical meetings for internal and external representatives
- Contributes significantly to the design of functional area goals and development
- Directs own technical leadership and project teams to more meaningful and/or productive ends
- To perform duties of a Trial Statistician to support clinical trials within national, regional or international development projects or for marketed products as required
- To contribute to the development of case report forms and to review for consistency with information needs for the protocol
- Show deep understanding of SAS computing package
- Be familiar with other relevant statistical computing packages such as nQuery
- Lead effectively multiple tasks and projects
- Provide statistical support for the clinical development
- He/she will work with the clinical teams in designing clinical studies, writing the statistical analysis plans, conducting the statistical analyses, and providing statistical support for the clinical study reports, scientific presentations and manuscripts
Qualifications for biostatistician senior
- Writing the statistics section a protocol or analyzing a clinical trial/case study
- Communicating basic statistical information to non-statisticians
- Attention to Detail – Possess a strong quality orientation
- Demonstrated highly advanced expertise in developing and incorporating novel methodologies into current processes and protocols
- Proven ability of excellent cross-functional project management skills, including an impressive track record of consistently meeting all project timelines and objectives
- MS level degree or equivalent in Biostatistics, Statistics or related field
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Biostatistician Senior Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of biostatistician senior. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for biostatistician senior
- Oversee junior-level biostatisticians on data cleaning and creation of analytic files and mentor junior-level biostatisticians in the area of conducting collaborative research
- Lead statistical projects related to collaborations on topics including the evaluation of statistical software or methods the development of novel methods, as need arises within QSU collaborative projects
- Consult with clinical and lab-based investigators on campus including the Heart Center, the Department of Medicine, the Department of Neurosurgery, and the Stanford Cancer to independently design studies and develop analysis plans
- Develop oral and written dissemination of findings for meetings with collaborators or for medical and/or statistical journal articles
- Contribute to Business Development activities, proposals and client presentations
- Become familiar with the activities outlined in the department’s Working Practice Documents and contribute changes as needed
- Write / review analysis plans and guide others on the team in its implementation
- Prepare reports, manuscripts, and other documents
- Provide input to the Directors, Associate Directors, and Managers as to hiring recommendations, department policies, and resourcing requirement.Assist in bidding and business development activities
- Perform duties of a Project Statistician to support high profile international development projects/trials or marketed products as required
Qualifications for biostatistician senior
- The ideal candidate will have at least two years of experience in SAS analysis of clinical trial data, 5-8 yrs preferred
- PhD in Biostatistics or Statistics
- 4–5 years in clinical research working for a nutritional company, or in Phase III trials for a pharmaceutical company
- 1–2 years experience in managing and directing support activity of Clinical Data Management (CDM), programming and statistics personnel, such as working with CROs
- Masters degree or educational equivalent in computer science or related field and 3 years relevant experience
- MS in Statistics or related discipline entry level, relevant work experience in statistical analysis of 8+ years required, including minimum of 5 years as study statistician
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Biostatistician Senior Job Description
Job Description Example
Our company is searching for experienced candidates for the position of biostatistician senior. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for biostatistician senior
- Advise on the design of valid, efficient and cost effective clinical trials and other research projects
- Direct analysis of data from major, prototypical phase II to IV trials incl
- Acts as a Trial or Project Statistician (TSTAT or PSTAT) for the trial/project
- Collaborate with the programming group and the data management group to submit very detailed timelines for the trial/project to clinicians
- 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)
- Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status
- Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required
- Analyze data from phase I to IV trials incl
- Participate on assigned international teams to promote harmonization efforts for clinical drug development
- Collaborate with the Biostatistics group and provide statistical support for research and development, quality initiatives, and complex clinical trial research as needed provide guidance on standards, processes, and other technical topics
Qualifications for biostatistician senior
- Knowledge of ADaM standards
- Bachelor’s degree or equivalent and 7 + years of experience OR Master’s degree in statistics/biostatistics/mathematics and 4 + years of experience OR PhD in statistics/biostatistics OR PhD in related disciplines with M.S
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution
- Extensive use of telephone, face-to-face communication requiring accurate perception of speech and of keyboard requiring repetitive motion of fingers
- Flexibility on travelling
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Biostatistician Senior Job Description
Job Description Example
Our growing company is looking to fill the role of biostatistician senior. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for biostatistician senior
- Provide state-of-the-art statistical strategies to meet business objectives by offering technical direction and leadership
- Resolve complex statistical issues from the business units and external customers
- Review protocols for proposed studies and IIS proposals with respect to statistical methodology as needed
- Provide statistical support during discussions with regulatory agencies
- Contribute to and co-author peer-reviewed articles independently and/or in coordination with the lead author/physician
- Manage resources and priorities
- Follow processes and adhere to our client's and project specific standards Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines)
- Performs statistical design, modeling and analyses
- Prepares statistical analysis plans, timelines for statistical project management and performs and interprets complex analyses
- Develop novel approaches to addressing complex problems in NGS data analysis
Qualifications for biostatistician senior
- To perform statistical analysis, then present and defend interpretation of study results through presentation of abstracts, papers and submission of publications
- To communicate with regulators, consultants, physicians, and other internal and external sources as needed to support submissions, analyses, presentations and publications
- PhD degree in statistics/biostatistics or related discipline with a minimum of 10 years relevant work experience across a broad range of biopharmaceutical statistics research activities
- SAS programming skills and familiarity of other statistical packages
- Experience with SAS Base and SAS Stat, strong data step skills
- Ability to work effectively and cooperatively with other professional staff members