Statistical Programmer

Job description

•      Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making.  B&I’s goal is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.

•      Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.  

Your responsibilities

• As a member of B&I Programming, collaborates with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:

- Data submission strategy (e.g., managing legacy data, pooling data)

- Responses to regulatory agency queries

- Tables Figures and Listings (TFLs)

- Development Safety Update Reports (DSURs)

- Periodic Benefit-Risk Evaluation Reports (PBRERs)

- Investigators brochures (IBs)

- Office of Scientific Investigations (OSI) data sets and listings

- Regulatory and/or Payer submission related analysis data sets and/or TFLs

- Associated quality and process documentation as per applicable business processes

- Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets

- Pharmacokinetics/pharmacodynamics data preparation and analysis

- Manipulating and analyzing adjudicated data

- Data preparation and analysis for Global Medical Affairs work

- Clinical Trial Transparency deliverables (data de-identification, results posting files)

- Timely upload of documents to eTMF

• Produce and maintain the technical database standards and Programming Specification documents.

• Contributes to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specifications and delivery of the SDTM and ADaM databases by these partners.

• Contributes to and/or lead the development of best practice to improve quality, efficiency and effectiveness.

• Identify opportunities to improve the methodology and provide practical solutions for problems.

Job Dimensions

• Lead the quality of own and the team's programming work as well as the completeness of applicable quality and process documentation.

• Accountable for good Information Practice on all assigned activities.

• When deployed to a B&I drug project team, operates under the leadership, direction and oversight of a Global Product Programmer (GPP) or her/his delegate.

• Indirect reporting relationship to the Global Product Programmer (GPP)/delegate on assigned drug project teams.

Our requirements

Essential:

•      BSc in mathematics, statistics, engineering, computer science, or life or social sciences.

•      Advanced SAS programming knowledge and experience.

•      Knowledge of database set-up and report publishing requirements.

•      Advanced knowledge of technical and regulatory requirements related to the role.

•      Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.

•      Advanced knowledge and experience of clinical drug development or healthcare.

•      Develop and deliver training.

Able to demonstrate team working and role leadership skills appropriate to level.

Desirable:

•      Advanced verbal, written, communication and collaboration skills.

•      Advanced problem solving and conflict resolution.

•      Helps drive others to work across global & functional boundaries.

•      Travel – willingness and ability to travel domestically and/or internationally.

•      Ability to apply programming knowledge and skills to problems and quality focus.  Troubleshoots for team.

•      Contributes to defining business processes and accurately completes and manages associated documentation.

•      Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.

 

•      Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.

Benefits

-remote work possibility

-real professional development opportunities

-working for a top company from pharmaceutical sector

-longtime cooperation

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