If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Project Lead, Statistical Programmingin Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Main Duties and Responsibilities
As Project Lead, Statistical Programming, you will be responsible for delivery of the technical components required to support the analysis and reporting for a complex project (i.e., a large, global project involving many different phases or a new and novel therapeutic area). You will also provide broad expertise in all aspects of the Programming field as well as critical clinical trial SAS programming and project management support to multiple projects. You will collaborate with external partners, ensuring partners have thorough understanding of expectations. You will provide oversight for programming deliverables performed by MedImmune’s functional service provider.
Additional responsibilities will include the following:
- Independently interact directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as the lead programmer.
- Efficiently coordinate activities of other SAS programmers assigned to projects.
- Proactively inform SAS management of the status of SAS programming deliverables, accomplishments and issues experienced and remediated on projects.
- Communicate and negotiate programming timelines to Clinical Trials Teams.
- Provide accurate estimates SAS programming resources to manager.
- Ensure compliance with MedImmune standards and SAS custom data listings, summary tables, and figures as specified in statistical analysis plan/statistical programming plan.
- Lead development of robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation.
- Assure the compliance of standards for self and other SAS programmers assigned to projects.
- Create good solutions for complex requests based on experience in delivering on successful solutions.
- Take initiative to provide SAS programming help when needed.
- Provide technical leadership on MedImmune functional initiatives (i.e., CTR, CDISC Implementation, etc.).
- Provide input in the creation and revision of SAS Programming Work Instructions and Standard Operating Procedures.
- Provide performance evaluation feedback for SAS programmers working on projects.
- BA/BS with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.
- Minimum 8 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.
- Superior SAS programming skills with proficiency in Base SAS SAS/STAT and SAS/Graph.
- Thorough understanding of CDISC guidelines.
- Broad familiarity of FDA regulations and GCP/ICH guidelines as related to clinical trial SAS programming and reporting processes.
- Advanced degree
- Ability to effectively work within and across functional teams and therapeutic areas in a global team environment
- Good knowledge of project management, resource utilization, and negotiating skills.
- Robust knowledge of medical terminology and clinical research trials methodology.
- Exceptional analytic and critical thinking, writing, and communication skills.
- Ability to proactively managing expectations on timelines for SAS programming deliverables.
- Excellent organizational, analytical, and collaborative skills with the ability to manage complexity and change in a dynamic environment.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.