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

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
9/20/2017
Position Type:
Full time
Job Code:
R-008121
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-008121
Posted date: May. 24, 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 Project Lead/Principal Statistical Programmer 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

Scope (Principal Statistical Programmer)

  • Provides critical clinical programming support to projects.
  • Proactively interacts directly with Biostatisticians, Data Management, Programmers, Clinical Development staff and management.
  • Coordinates activities of programmers assigned to the project and provides mentorship to increase their technical programming skills.
  • Communicates with the Project Lead and/or manager on the status of the technical programming work supporting the Clinical Trials Teams (CTT) on any issues, including the strategy to remediate.
  • Implements self-initiated projects that improve the technical skills of the programmers and provide efficient and effective programming solutions to the CTT.
  • Supports the CTT by providing resource estimates for programming and timelines for delivery of the work. 
  • Leads the development and documentation of mapping specifications for creating analysis datasets.
  • Implements standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan for inclusion in the clinical study report.  Responds to ad-hoc requests from the CTT.
  • Develop robust, flexible SAS macro programs, modules and applications.
  • Challenges conventional practices and creates/implements novel systems and procedures to enhance productivity and / or add new functionality.
  • Assures the compliance of standards for self and other programmers assigned to projects.
  • Reviews and provides feedback of case report form designs, eCRF annotations, dB structures, edit checks, SAPs and SPPs.
  • Mentors and trains programmers on MedImmune standards and practices as well as SAS technical skills.
  • Independently creates superior solutions for complex requests.
  • Plays a lead or major programming role on multiple protocols, projects and across multiple initiatives.
  • Consults with other project teams on implementing superior technical solutions.

Scope (Project Lead)

  • 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).
  • Provide broad expertise in all aspects of the Programming field.
  • Provides critical clinical trial SAS programming and project management support to multiple projects.
  • Collaborates with Global Programming Leader or external partners, ensuring partners have thorough understanding of expectations via reverse knowledge transfer.
  • Independently interacts directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as the lead programmer.
  • Efficiently coordinates activities of other SAS programmers assigned to projects.
  • Proactively informs SAS management of the status of SAS programming deliverables, accomplishments and issues experienced and remediated on projects.
  • Communicates and negotiates programming timelines to Clinical Trials Teams.
  • Provides accurate estimates SAS programming resources to manager.
  • Ensures 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.
  • Assures the compliance of standards for self and other SAS programmers assigned to projects.
  • Creates good solutions for complex requests based on experience in delivering on successful solutions. 
  • Takes initiative to provide SAS programming help when needed.
  • Provides technical leadership on MedImmune functional initiatives (i.e., CTR, CDISC Implementation, etc.).
  • Provides input in the creation and revision of SAS Programming Work Instructions and Standard Operating Procedures.
  • Provides performance evaluation feedback for SAS programmers working on projects.

Requirements

Essential Requirements

Education and Experience (Principal Statistical Programmer)

  • Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree preferred
  • A minimum of 10 years of clinical trial programming experience using SAS within the pharmaceutical, biotechnology, and/or contract research organization industries.

Education and Experience (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 (Principal Statistical Programmer)

  • Expert SAS programming skills with proficiency in Base SAS and its macro facility, SAS/STAT and SAS/GRAPH. 
  • Thorough understanding of CDISC guidelines. 
  • Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes.
  • Good knowledge of medical terminology and clinical trials methodology.
  • Excellent verbal, written and interpersonal communication skills. 
  • Excellent collaborative skills and the ability to manage complexity and change in a dynamic environment.
  • Detail-oriented with sound judgment and flexibility.  Advanced knowledge of project management and resource utilization skills.

Special Skills/Abilities (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