Senior Manager, Clinical Programming

2 weeks ago

Butler, United States Tevapharm Full time

The opportunity The Clinical Programming Senior Manager is responsible to manage the timely and accurate execution of programming components of clinical trials. The Senior Manager leads and manages completed projects, that involved global tasks or cross functional teams or outsourcing resources. The role may require providing inputs to design and analysis, and report the results of clinical trials including programming rules and mocked T/L/G; In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs. How you’ll spend your day Being able to accomplish all the major duties of Clinical Programming Manager. Leading global projects with cross functional involvement and required project management and leadership capabilities. Supervise or mentor CROs or outsourcing programmers. Providing strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets. Have good knowledge of understanding the statistical models in efficacy data analysis. Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource issues. Core member of clinical team and main programming contact with the statistician and project physician. Responsible for the standardization of Biometrics deliverables across study projects within an indication/therapeutic area. Responsible for the overall definition of programming rules and standardization across therapeutic areas and/or indication. Coordinating Clinical Programming resources, priorities and timelines with the clinical team Participation in project team meetings. Extending existing or development new clinical programming methods to solve complex problems. Ensuring the accuracy and validity of data displays. Ensuring the accuracy and validity of the study database (SDTM) and/or analysis database (ADaM).. Primary responsible for all programming deliverables for NDA/MAA/IND/PSUR. Work closely with Statistics group for the production of tables, listings, and graphs as applicable. Mentor and train selected associates within the Biometrics group for SAS programming; participation in project team meetings. Miscellaneous activities directed by management. Your experience and qualifications Education Required: Bachelor's or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience. Experience Required: 10+ years of professional experience in pharmaceutical or clinical research. Functional Knowledge: Excellent SAS knowledge of the following SAS modules/ procedures: Base SAS; SAS report writing; SAS macrosunctions. Enjoy a more rewarding choice We are strengthening and adding to our critical teams with great talent and capabilities: Teva, a global organization with a brand of evolving success. Be part of it We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, Paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance. Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. #J-18808-Ljbffr

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