As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients’ and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
Supports the clinical research development process by providing statistical programming for new substances, indications or marketing claims. Functions as the Trial Statistical Programmer (TProg) or Trial Statistical Programmer for Translational Medicine and Clinical Pharmacology (TProg-TMCP) for clinical trials of any complexity or supports a Project Programmer (PProg) as a co-PProg or co-PProg-TMCP.
Utilize BI SOPs and guidelines, trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I - IV. Gain specific knowledge about the clinical data collected for the trial. Attend trial meetings as necessary (e.g. Trial Preparation Meeting, Medical Quality Review Meeting, and Blinded Report Planning Meetings). Communicate with other trial team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines.
Produce non-standard edit check and monitoring programs to support the clinical trial team in the medical and quality review of the data during trial conduct.
Review and provide feedback to the trial statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs. Author or co-author the Analysis Data Set (ADS) specification with the statistician. Challenge the Technical TSAP to ensure the most standardized and efficient processes can be used for its implementation. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicate and collaborate with the CRO programmer when any part of the programming is outsourced.
Transform specifications in the Trial Statistical Analyses Plans (TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods. Reviews the TLFs across the displays for consistency prior to review by the statistician.
Provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy data files, application programs and documentation. Performs quality control activities to ensure the quality of the electronic submission.
Establish project and substance databases following the rules of good data base structure and data base integrity. The structure of the data base must support the execution of the standard safety macros.
Provide fully documented and tested programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB), etc. Reviews TLFs for consistency across displays prior to sending package to the statistician.
As a Co-PProg or co-PProg-TMCP support the project programmer in analyses activities to support submissions. Examples could be validation programming, quality control of finalized outputs, or draft authoring of project ADS plans.
Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid in the efficiency for the department.
Helps create or provide training materials in supported area.
Maintain technical competence in selected areas, by keeping abreast of new and emerging technologies in hardware and software development with the purpose of increasing the overall efficiency or effectiveness in the department.
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Vetmedica Inc. is an equal opportunity employer. M/F/D/V
Bachelors of Science degree in a technical area such as computer science, or math and five years of programming experience or a Master’s of Science degree in a technical area and three years of programming experience.
Good working knowledge of SAS macros, Proc SQL, Proc Report, SAS graphics and statistical procedures. Knowledge of the CDISC standards especially SDTM and ADaM.
Good working knowledge of statistical concepts in support of analyses and reporting in both SAS and R.
Knowledge in database structures and set-up.
Basic knowledge of medical terminology.
Good organizational skills, problem-solving abilities, time management skills and initiative. Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team. Some travel may be required (e.g. team meetings, training). Good written and oral communications skills in the English language.
Must be precise, detail oriented, and able to understand data displays and their relation to each other.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Boehringer Ingelheim is a research-driven group of companies dedicated to the discovery, development, manufacture and marketing of innovative health care products. We are committed to offering the highest quality products to treat diseases, enhance health, and improve the quality of life for patients and their families.