Welcome to Orano
Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Job description
General Summary:
The Sr. Statistical Programmer will be responsible for statistical programming support for clinical trials and programs including submissions to Health Authorities. The position will also support in-house ad hoc programming requests (e.g. for abstracts or publications).
Job Duties and Responsibilities:
- Collaborate with biostatisticians, data managers, and clinical study teams to ensure the accurate and timely delivery of data and analysis results on assigned studies and programs.
- Serve as the primary point of contact for statistical programming, coordinate outsourced programming activities.
- Oversee outsourced statistical analysis and reporting deliverables (e.g. safety, efficacy analysis datasets, tables, listings and figures) to ensure compliance with industry standards (CDISC, SDTM, ADaM) and applicable regulatory guidelines.
- Ensure data packages for health authority submissions comply with applicable submission requirements.
- Maintain statistical datasets that will support clinical development and safety.
- Provide statistical programming support for ad-hoc requests (e.g. abstracts, posters, publications etc.)
Our Full-Time Benefits
- Competitive compensation
- Health, Dental, and Vision insurance – with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
- and more…
Ideal qualifications
All candidates must meet the following minimum requirements in order to be considered for this opportunity.
Minimum Qualifications:
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
- A minimum of 5-7 years of experience in statistical programming in the pharmaceutical or biotechnology industry.
- Proven experience in supporting NDA submissions to the FDA.
Differentiating Qualifications:
- Experience with regulatory agency interactions and audits is preferred.
Skills and Knowledge Required:
- Extensive experience with SAS and in clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
- Strong understanding dataset submission requirements in support of approval applications.
- In-depth knowledge of CDISC standards, including SDTM and ADaM.
- Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts.
- Familiarity with clinical data management concepts
- Experience assuring programming consistency across protocols and projects.
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.
Orano Med
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Find out more about Orano Med
Find out more about Orano Med
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