Senior Statistical Programmer
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 industry’s 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:
- Perform the work of statistical programming services to achieve quality, timely and cost-effective study deliverables.
- Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
- Remain informed of new developments in statistical programming that are relevant to the industry and support to the innovation of new reporting systems.
- Support the creation of statistical programming standards that comply with regulatory requirements, and increase efficiency and quality across studies.
- Contribute to the creation of standard macros and/or tools in SAS for data analysis and reporting.
- Assist with statistical quality assurance review.
- Contribute to the design and use of appropriate data collection and quality control methods.
- Mentor and train selected Associates within the Biostatistics and Data Management department.
- 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.
- Serves as lead when conducting the work of statistical programming services to achieve quality, timely and cost-effective study deliverables.
- Provide strategic support regarding statistical programming methodology.
- Contribute to statistical programming standards that comply with regulatory requirements, and increase efficiency and quality across studies.
- Develop and/or contribute to the creation of standard macros and/or tools in SAS for data analysis and reporting.
- Propose creative solutions to identified problems.
Qualifications & Technical Competencies:
- Bachelor’s degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or
- Master’s 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.
- Experience with SAS programming projects in the pharmaceutical or medical device industry demonstrated by the ability to independently act as the point of contact on the statistical programming for all phases of clinical trials
- Fluency in English and local language, if different, required.
- Knowledge and experience with SAS programming language.
- Ability to organize and manipulate large datasets.
- Ability to express complex statistical programming concepts and technical information.
Working Conditions:
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
- Extensive use of a computer keyboard.