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AssociateorStatistical Programmer or Sr. Statistical Programmer orPrincipal Statistical Programmer

Description:   The Statistical Programmer supports the clinical research development process by providing statistical programming for new substances, indications or marketing claims. The Senior Statistical Programmer supports the clinical research development process by providing statistical programming for new substances, indications or marketing claims and is able to function as a Project Statistical Programmer (PPROG), Project Statistical Programmer for Translational Medicine and Clinical Pharmacology (PProg-TMCP) or as the Trial Statistical Programmer (TPROG) or Trial Statistical Programmer for TMCP (TProg-TMCP) focusing on complex trials that represent new challenges and for which project and therapeutic knowledge is not given, such as mega trials in new indications. The Principal Statistical Programmer functionally leads a team of project programmers to fulfil the magnitude of all necessary tasks, represents the department on International Working groups, is recognized outside of the company by manuscript publication and presentations at conferences, and participates in external associations such as the CDISC standards committees.   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   Duties & Responsibilities: 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. As a PPROG or PPROG-TMCP, provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of TMCP analyses or safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation activities to ensure the quality of the submission. Keep abreast of international data standards (e.g. CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities. 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 CROprogrammer when any part of the programming is outsourced. Transform specifications in the Project and Trial Statistical Analyses Plans (P/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; implementation of tables as specified in the MQR plan. 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 electronic documentation and user manuals.  Performing validation activities to ensure the quality of the submission.  Keep abreast of CDISC/ADAM international data structures and supply any programming support to the project team to accomplish this requirement from the FDA. Ensures data base standards are adhered to and referential integrity is followed.  Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department's overall efficiency. The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well. Define critical steps and decisions to be made to enable timely reporting in phase III on trial and project level. Implement project programs as much as possible and enable usage across trials. Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status and issues. Represents the Statistical Programming function on multi-disciplinary, international working groups, with the ability to lead international working groups. Helps create or provide training materials in supported area. Communicate and collaborate with the CROprogrammer when part of the trial programming or double programming is outsourced, providing any necessary oversight. Proactively propose effective and efficient implementation methods of TMCP related statistical aspects. Translation of statistical analyses of Clinical Pharmacology (CP) and Biomarker (BM) data on trial and project level into programming code using R and SAS. Support the statistical implementation TMCP parts of submission package (e.g. integrated & meta-analysis of PGx, BM, PK/PD) & exploratory data analysis of TMCP trials. Support the development of TMCP specific programming tool box, e.g. clustering, re-sampling, simulations.   Associate Programmer Requirements:  Bachelor of Science required in Bio-/Applied-/ Statistics, Math, and Computer Science (or similar degree that focus on software and programming language, i.e. C/C++, JAVA, PERL, and Python) required and a minimum 2 years of statistical programming experience with pharmaceutical industry, CROs, academic sites. With a Master of Science, degree in Bio-/Applied Statistics required with course work specific to SAS programming and some exposure to clinical research; 0 years of experiencerequired Good working knowledge of SAS programming language Knowledge of statistical concepts in support of analyses and reporting Knowledge in database structures and set-up Knowledge of basic medical terminology Ability to work successfully in teams. 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. 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.   Statistical Programmer Requirements: Bachelor of Science required with a preferreddegree (but not limited to) in Bio-/Applied-/ Statistics, Math, and Computer Science (that focus on software and programming language, i.e. C/C++, JAVA, PERL, JSP and Python) and a minimum 5 years of statistical programming experience within the pharmaceutical industry, CROs or academic sites is required.  With a Master of Science in the preferreddegrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science (that focus on software and programming language, i.e. C/C++, JAVA, PERL, JSP and Python), a minimum of 3 years of statistical programming experience is required within the pharmaceutical industry, CROs or academic sites is required.  Proficient in the use of SAS programming language. Good working knowledge of statistical concepts in support of analyses and reporting of clinical trials. Knowledge in database structures and set-up. Knowledge of basic medical terminology. Ability to work successfully in teams. 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. 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.   Senior Statistical Programmer Requirements: Bachelor of Science required with a preferreddegree (but not limited to) in Bio-/Applied-/ Statistics, Math, and Computer Science (that focus on software and programming language, i.e. C/C++, JAVA, PERL, JSP and Python) and a minimum 7 years of progressive statistical programming experience within the pharmaceutical industry, CROs or academic sites is required.   With a Master of Science in the preferreddegrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science (that focus on software and programming language, i.e. C/C++, JAVA, PERL, JSP and Python), a minimum of 5 years of progressive statistical programming experience within the pharmaceutical industry, CROs or academic sites is required International business experience Proven experience within the pharmaceutical industry, CROs or academic sites, covering MQR programming and all CTR aspects - ADS / TFLs. Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming. Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission Having background of applied statistics Knowledge of new advanced statistical methods using R and SAS Knowledge in database structures and set-up Knowledge of basic medical terminology Ability to work successfully in teams. 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. 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. Principal Statistical Programmer Requirements: Bachelor of Science required with a preferreddegree (but not limited to) in Bio-/Applied-/ Statistics, Math, and Computer Science (that focus on software and programming language, i.e. C/C++, JAVA, PERL, JSP and Python)  and a minimum 10 years of statistical programming experience within the pharmaceutical industry, CROs or academic sites is required.   With a Master of Science in the preferreddegrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science (that focus on software and programming language, i.e. C/C++, JAVA, PERL, JSP and Python), a minimum of 8 years of statistical programming experience is required within the pharmaceutical industry, CROs or academic sites is required.  One (1) to three (3) years project management experience International business experience Proven experience within the pharmaceutical industry, CROs or academic sites Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming. Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission Having solid background of applied statistics Solid knowledge of new advanced statistical methods using R and SAS Knowledge in database structures and set-up Knowledge of basic medical terminology The person carrying out this function has successfully provided programming expertise at the Project level for at least two large and complex international development projects that have been submitted to regulatory agencies worldwide and is an expert statistical programming resource for the department.    Ability to work successfully in teams. 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. 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. Eligibility Requirements: 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) Must be 18 years of age or older 183166
Salary Range: NA
Minimum Qualification
Less than 5 years

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