Statistical Programming Summer Intern for Clinical Research
Boehringer Ingelheim Ridgefield, CT
Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our Biostatistics and Data Science department located at our Ridgefield, Connecticut facility. As an Intern, you will support the clinical research development process in the field of clinical trial programming. The intern will learn and apply CDISC standards for an ongoing trial within the standard BI setting as documented through BI SOPs, guidelines and working instructions.
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:
Utilizes BI SOPs and guidelines, the trial protocol, annotated case report forms, trial and project data handling rules and standards and the Statistical Analyses Plan in preparation for the programming of the Medical Quality Review Plan (MQRP) and the safety tables, listings and graphs (TLG) required for the Clinical Trial Report (CTR). Gains specific knowledge about the clinical data collected for the trial.
Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting.
Review the programming specifications and table mockups in the Trial Statistical Analyses Plan (TSAP) for completeness, correctness and adherence to sited department guidelines and SOPs. Ensure all programming issues are resolved and updated in the TSAP. Ensure additional specifications once programming commences are properly documented.
Transform specifications in the Trial Statistical Analyses Plan (TSAP) into fully documented, validated programs required for the Clinical Trial Report. This includes required standard displays, safety displays of moderate complexity unable to use a standard macro that are well specified by the trial team, and efficacy related tables, listings and figures.
Requirements:Must be an Undergraduate, Graduate, or Professional Student in good academic standing.Must have completed 12 credit hours within a related major and/or other related coursework.Overall, cumulative GPA (from last completed quarter) must be at least 3.000 (on 4.0 scale) or better (No rounding up).Major must be related to the field of internship. Desired Experience, Skills and Abilities:
Must be a Master of Science graduate student in fields related to Bio/statistics, Computer Science (software programming language focused), Data Science, or a related degree program with some exposure to clinical research and statistical programming in SAS or R.
Good written and oral communications skills in the English language.
Knowledge in database set-up, data processing, elementary statistics and basic medicine terminology is desired.
Good organizational skills, problem-solving abilities, time management skills and initiative is desired as well as flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team.
Must be precise, detail oriented, and able to detect subtle inconsistencies in the data
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. Who We Are:At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings. Job - Apprenticeship/Internship Primary Location - Americas-US-CT-Ridgefield Organization - US-BI Pharma/BI USA Schedule - Full-time
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