Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Cambridge

Description

MedImmune is the worldwide biologics research and development arm of AstraZeneca. We have one of the most robust pipelines in the industry. You will have the opportunity to make a difference in people’s lives every single day. As one of the world’s best-in-class biotechnology companies, our mission is centered on delivering life-changing medicines. MedImmune has a dynamic environment that fosters teamwork and innovation. We attract top minds, and we nurture and build top talent. If you are passionate about the possibilities of science to change lives and you thrive when making brave decisions – join us.

Within our Statistical Programming department, we are looking for a statistical programmer to join the team aligned to Respiratory, Infectious Diseases, and Vaccines. Depending on your experience we will consider you as a Senior Statistical Programmer (SSP) or Principal Statistical Programmer (PSP). The role is a full-time office-based position in our Cambridge, UK site.

Position Summary:

As SSP or PSP, you are acting in a delivery focused role responsible for programming clinical trial analysis deliverables with quality and timeliness, following established standards and processes. We require you to utilise your technical skills and clinical study knowledge to independently perform programming tasks while using your judgement about seeking guidance in complex situations.

This is a rare opportunity where you are part of an integrated clinical development team based in Cambridge and collaborate with clinical operations representatives, study biostatisticians and medical directors. You will be involved in a number of projects with one of our key biologics being investigated across multiple indications. Are you feeling a lack of collaboration in your current role, and you are keen about working with one of the most promising drug projects?

Major Responsibilities:

Review clinical study protocols with regard to statistical programming responsibilities
Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP)
Review and edit Case Report Forms (CRFs) and external data transfer agreements
Collaborate with study team members including but not limited to the biostatistician, lead statistical programmer, data manager, and medical writer.
Work cooperatively with and oversee a contract programming provider
Develop and maintain SDTM and ADaM specifications
Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications
Understand and align with MedImmune programming standards and data standards
Provide accurate programming time estimates to management or a study team
Actively inform management of the status of statistical programming deliverables and issues
Meet delivery timelines for multiple concurrent studies
Contribute to standards or process improvements
Additional responsibilities at the PSP level include:

Hold clinical study team members accountable for their contributions
Assign tasks, set priorities, and provide technical help to study programmers
Enforce compliance with MedImmune programming standards and data standards
Provide risk mitigation plans for deliverables
Oversee on-time delivery from clinical study programming teams
What we need from you:

A degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field, coupled with proven experience in SAS programming in clinical studies

Required Skills

Advanced SAS programming skills; competent with macro programming
Able to communicate clearly in oral or written form
Working knowledge of CDISC standards and lab data processing
Practical knowledge of medical terms, the data coding process, and coding dictionaries
Working knowledge of regulatory agency processes.
Additional required skills at the PSP level include:

Contribute programming to a global library of macros
Apply CDISC standards to complicated data
Resolve lab data issues
Apply regulatory agency guidelines in statistical programming responsibilities
Preferred Skills:

Ability to program in other languages (e.g. R or S-PLUS, VBA, or Perl)
Practical knowledge of Unix commands; able to program shell scripts
Advanced knowledge of inferential statistics
Supervision:

Able to perform technical work independently and show good judgement about asking for guidance
In addition at the PSP level, oversee a clinical study programming team
Next Steps – Apply today!

To be

About the company

AstraZeneca is a global, science-led biopharmaceutical company that spans the discovery, development, manufacturing, distribution and worldwide commercialisation of primary care and speciality care medicines.

We believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.

We invest in distinctive science in three main therapy areas where we believe we can make the most meaningful difference to patients: oncology; cardiovascular and metabolic diseases; and respiratory, inflammation and autoimmunity. Our science exploits our rare combination of capabilities in small molecules and biologics, immunotherapies, protein engineering technologies and devices. These are reinforced by a strong focus on translational science and personalised healthcare capabilities. We build on our own capabilities by collaborating with world-renowned scientists and academic institutions and partnering with like-minded science-led companies.

Through leading in science, we are confident that we can transform the lives of people around the world and deliver value to our shareholders.

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