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Director, Statistical Programming

Company: Organon & Co
Location: Saint Louis
Posted on: November 22, 2021

Job Description:

Job Description Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated against COVID-19 or intend to be fully vaccinated against COVID-19, by November 24, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not fully vaccinated by November 24, 2021 with a vaccine authorized or approved by the Food and Drug Administration (FDA), and who have not been approved for a legally required medical or religious accommodation, will no longer meet the requirements for employment, and therefore will be considered to have voluntarily resigned their employment, in accordance with applicable law. Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people. We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress. At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets. It's going to be an exciting future-come be a part of it! The Director, Statistical Programming is responsible for providing statistical programming solutions to all clinical development programs, regulatory submissions, and internal initiatives. Primary Responsibilities: Develop programming standards for data directories, programming macros and outputs, and data anonymization. Oversight and QC of external vendors. Collaborate with biostatistics, data management and others to provide technical support for ongoing trials, FDA submissions, publications and other business needs. Provide expert-level hands-on support for all internal statistical programming needs including but not limited to ISS and ISE summaries and exploratory data analyses. Write or review and approve data specifications for SDTM and ADaM. Create or validation SDTM, ADaM, and TLFs. Preferred Experience and Skills: Minimum 10 years of statistical programming experience in CRO, biotech or pharmaceutical industry. Prior supervisory experience preferred. Advanced knowledge in GCP/ICH standards and FDA requirements with prior experience filing an NDA/MAA/BLA. Ability to manage multiple projects and shifting priorities. Experience working with an outsourced model. Excellent written and oral communication skills. Expert level understanding and hands on application of SAS programming skills and working experience in CDISC Education Minimum Requirements: Bachelor's Degree required, preferably in Statistics, Mathematics, or Computer Science Master's degree preferred. Who We Are: Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. Residents of Colorado: to request this role's pay range: email: coloradopayact@organon.com US and PR Residents Only If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 Requisition ID:R504758

Keywords: Organon & Co, St. Louis , Director, Statistical Programming, Executive , Saint Louis, Missouri

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