Sr. Biostatistician (US Remote)

NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.

We have become the industrys premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization whose:
Mission is to make a scientific contribution to every medical device in the world.
Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
Values have stood the test of time.
Above all else, conduct ourselves with integrity


Job Description:

Serve as statistician for research studies.
Author Statistical Analysis Plans.
Provide data analysis, tables and graphics for statistical reports provided to researchers and Medical Research Managers.
Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
Interpret results of analysis for a wide variety of audiences.
Contribute to the design and use of appropriate data collection and quality control methods.
Promote good statistical practice for the support of sound scientific judgments.
Perform project in compliance with regulations.
Develop positive relationships with clients, as well as with NAMSA colleagues.
Function at a level that affords respect by internal NAMSA Associates/team members.
Ensure schedule, budget and quality commitments are met for the client, within the scope of control.
Communicate project/team issues to project Medical Research Manager and/or NAMSA C&C Management.
Handle challenging situations, communicate to project Medical Research Manager, and know when to call-in help.
Contribute to presentations, including preparation, assembling slides, and speaking.
Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
Participate in meetings with prospective clients.
Provide scope of project and relevant information to support the creation of proposals.
Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
Determine statistical support requirements, negotiate timelines and coordinate work of statistical team supporting research projects.
Prepare Statistical Analysis Plans, table shells, analysis specifications, and statistical reports; conduct statistical programming primarily in SAS; oversee validation process.
Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
Prepare statistical sections of protocols, study reports and manuscripts, and review these documents for accuracy and appropriate interpretation.


Qualifications & Technical Competencies:


North American Science Associates (NAMSA) is a rapidly growing, global organization. We are always looking to connect with top talent in our industry. If you are interested in learning more about NAMSA and the FUTURE position below, please apply so we can start the conversation with you TODAY!



SUMMARY OF SENIOR BIOSTATISTICIAN



As a member of the Clinical Services group, this critical position requires a person who is a passionate about mathematics, working with data with a desire to contribute to work that mattersas you author statistical analysis plans. At a high level, you serve as a statistician who gathers, analyzes, and interpret data for research studies. You will also add value to this work by utilizing your SAS and programming skills. Qualify or advance within this role of strategic and multifaceted levels, i.e., Biostatistician, Senior Biostatistician, Principal Biostatistician and Sr. Principal Biostatistician. Opportunity for learning and growth is available within the group and throughout NAMSA.


KeyDuties and Responsibilities:



Biostatistician

Serve as statistician for research studies.
Author Statistical Analysis Plans.
Provide data analysis, tables and graphics for statistical reports provided to researchers and Medical Research Managers.
Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
Interpret results of analysis for a wide variety of audiences.
Contribute to the design and use of appropriate data collection and quality control methods.
Promote good statistical practice for the support of sound scientific judgments.
Perform project in compliance with regulations.
Develop positive relationships with clients, as well as with NAMSA colleagues.
Function at a level that affords respect by internal NAMSA Associates/team members.
Ensure schedule, budget and quality commitments are met for the client, within the scope of control.
Communicate project/team issues to project Medical Research Manager and/or NAMSA C&C Management.
Handle challenging situations, communicate to project Medical Research Manager, and know when to call-in help.
Contribute to presentations, including preparation, assembling slides, and speaking.
Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
Participate in meetings with prospective clients.
Provide scope of project and relevant information to support the creation of proposals.
Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.


Senior Biostatistician

In addition to the items listed above:
Determine statistical support requirements, negotiate timelines and coordinate work of statistical team supporting research projects.
Prepare Statistical Analysis Plans, table shells, analysis specifications, and statistical reports; conduct statistical programming primarily in SAS; oversee validation process.
Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
Prepare statistical sections of protocols, study reports and manuscripts, and review these documents for accuracy and appropriate interpretation.


Principal Biostatistician

In addition to the items listed above:
Serve as lead statistician for research studies.
Function as a statistical resource (consultant) for research staff on such topics as study design, sample size calculations, analysis methods.
Propose creative solutions to identified problems.
Develop presentations, including preparation, assembling slides, and speaking.
Effectively work and communicate with senior management.
Speak at conferences, webinars, or other venues.


Senior Principal Biostatistician

In addition to the items listed above:
Provide strategic support regarding statistical methodology.
Serve as lead statistician for large, complex research studies, responsible for all statistical aspects of the study.
Oversee the creation of Statistical Analysis Plans, table shells, analysis specifications, and statistical reports; conduct statistical programming primarily in SAS; oversee validation process.
Interpret results of analysis for a wide variety of audiences, including FDA Advisory Panels and other high-profile audiences.
Guide the preparation of statistical sections of protocols, study reports and manuscripts, and review these documents for accuracy and appropriate interpretation.
Contribute to the development or improvement of systems to assure the timely provision of high quality statistical services.
Investigate statistical literature for appropriate methodologies and solutions to challenging situations.
Develop positive relationships with Regulators, clients including executive level individuals, as well as with NAMSA colleagues.
Assist in driving the schedule, budget and quality commitments on behalf of the client.
Identify opportunities to bring in new projects/clients.
Propose and implement systems to support internal improvement and NAMSAs long-term growth.



Qualifications and Skills
:


Biostatistician

Bachelors degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or
Masters or Doctorate degree in Biostatistics, Statistics, Epidemiology, Applied Math (or similar) or equivalent experience in a related field, and a minimum of 2 years of relevant experience.
Fluency in English and local language, if different, required.


Senior Biostatistician

Bachelors degree or equivalent experience in a related field, and a minimum of 8 years of relevant experience; or
Masters or Doctorate degree in Biostatistics, Statistics, Epidemiology, Applied Math (or similar) or equivalent experience in a related field, and a minimum of 4 years of relevant experience.
Fluency in English and local language, if different, required.


Principal Biostatistician

Bachelors degree or equivalent experience in a related field, and a minimum of 12 years of relevant experience; or
Masters or Doctorate degree in Biostatistics, Statistics, Epidemiology, Applied Math (or similar) or equivalent experience in a related field, and a minimum of 6 years of relevant experience.
Fluency in English and local language, if different, required.


Senior Principal Biostatistician

Bachelors degree or equivalent experience in a related field, and a minimum of 14 years of relevant experience; or