Senior Statistical Programmer

3 weeks ago

Plano, Texas, United States Orano Med, LLC. Full time

Clinical Trials Data Analyst

**Job Summary**

We are seeking a highly skilled Clinical Trials Data Analyst to join our team at Orano Med, LLC. As a key member of our statistical programming team, you will be responsible for providing statistical programming support for clinical trials and programs, including submissions to Health Authorities.

**Key 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.)

**Requirements**

* 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.
* 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.

**What We Offer**

* 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...

**Equal Opportunity Employer**

Orano Med, LLC 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.

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