Senior Statistical Programmer/Project Lead - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
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Senior Statistical Programmer/Project Lead - (Gaithersburg, MD)

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
8/21/2017
Position Type:
Full time
Job Code:
R-009850
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-009850
Posted date: Jun. 26, 2017

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 Senior Statistical Programmer/Project Lead in 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

Senior Statistical Programmer

As a Senior Statistical Programmer you will provide critical clinical programming support to projects and interact directly and independently with Biostatisticians, Data Management, Programmers, Clinical Development staff and management as a fully functioning member of the clinical programming team.  You will proactively keep the manager updated on the status, programming accomplishments and criticality of any issues impacting the quality and timely delivery of SAS Programming outputs.  You will work independently, with minimal supervision from the manager and actively solicit feedback from manager to address any issues and/or complex problems.  You will provide accurate estimates on timelines and lead in the development of analysis data set specifications.  You will independently implement and champion the use of standards and TA specific data listings, summary tables, and figures as specified in statistical analysis plan in the clinical study report.  You will develop robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation.  You will ensure compliance of standards for all SAS programming assignments and will review and provide feedback on eCRF designs, eCRF annotations, DB structures, edit checks, SAPs and SPPs.  You will proactively offer and provide SAS programming and analytical skills that support clinical trial and/or TA projects and programs.

Project Lead

As the Project Lead 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 provide broad expertise in all aspects of the Programming field and provide critical clinical trial SAS programming and project management support to multiple projects.  You will collaborate with Global Programming Leader or external partners, ensuring partners have thorough understanding of expectations via reverse knowledge transfer.  You will independently interact directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as the lead programmer.  You will efficiently coordinate activities of other SAS programmers assigned to projects and proactively inform SAS management of the status of SAS programming deliverables, accomplishments and issues experienced and remediated on projects.  You will communicate and negotiate programming timelines to Clinical Trials Teams and provide accurate estimates SAS programming resources to manager.  You will ensure compliance with MedImmune standards and SAS custom data listings, summary tables, and figures as specified in statistical analysis plan/statistical programming plan.  You will lead development of robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation.  You will assure the compliance of standards for self and other SAS programmers assigned to projects and create good solutions for complex requests based on experience in delivering on successful solutions.  You will take initiative to provide SAS programming help when needed and Provide technical leadership on MedImmune functional initiatives (i.e., CTR, CDISC Implementation, etc.).  You will provide input in the creation and revision of SAS Programming Work Instructions and Standard Operating Procedures and provide performance evaluation feedback for SAS programmers working on projects.

Requirements

Education and Experience

Senior Statistical Programmer

  • Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree preferred. 
  • A minimum of 5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.

Project Lead

  • Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree in Statistics preferred. 
  • A minimum of 8 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries

Special Skills/Abilities

Senior Statistical Programmer

  • Has acquired advanced SAS programming skills with proficiency in Base SAS, SAS/STAT and SAS/Graph.
  • Able to develop standard SAS macros.
  • Good working knowledge of CDISC guidelines. Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes.
  • General knowledge of medical terminology and clinical trials methodology.
  • Excellent verbal, written, interpersonal and communication skills.
  • Sound negotiation skills.
  • Ability to mentor junior SAS programmers
  • Fully understands data interoperability across and amongst the Clinical Data Management

Project Lead

  • 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.
  • 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 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. 
  • 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.

*LI-MEDI