Study Lead Programmer

Plan and execute high quality and timely statistical programming deliverables within a late phase study in Rare Diseases and Rare Blood Disorder projects. In addition, contribute to the therapeutic area and department initiatives and task forces for innovation and process improvements.

Major Responsibilities

Programming Study Lead (SP) of a late phase study / early phase project. With limited direction from programming project leader, plan and execute statistical programming activities for the responsible study.

• Perform programming activities for all statistical deliverables within a study/project, e.g. SDTM, ADaM, Tables Listings and Figures (TLF) for Data Monitoring Committee Reports (DMC, if any), Interim Analysis (if any), Clinical Study Report, DSUR, Transparency (Eudract, CTGov, Lay Summary), Data Surveillance Report, Publications and any exploratory analyses

• Perform quality control for statistical programming deliverables, propose to the PPL the validation plan and completes the associated documentation: Validation plan and quality control (QC) documentation

• Review and provide feedbacks on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and Table Listing and Figures (TLF) templates.

• Write and provide the programming specifications for the Study Data Tabulation Model (SDTM) and Analysis Datasets Model (ADaM) for a study

• Provide items required for an electronic submission (following regulatory requirements)

• Ensure compliance to department SOP’s, standards, and guidelines

• Collaborate with study statistician and PPL

• Collaborate with data management team on data issues

• Collaborate with external partners and support outsourcing oversight activities

• Participate in working groups within the department

• Support department initiatives and contributes to department standards and processes

• Provide in timely manner the archiving of any programming documents in the CTP

Required Education/Experience

• Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.

• MS / BS with at least 2 / 4 years of programming experience preferably in processing clinical trial data in the pharmaceutical industry

• Advanced SAS and other statistical computing software skills (e.g., R, Python) in a clinical data environment across multiple therapeutic areas, thorough understanding of relational databases and their correlation to submission-ready database structure (CDISC data structure requirements)

• Excellent knowledge of Good Programming Practices

• Proven communication and coordination skills

• Ability to plan and perform the preparation, execution, reporting and documentation of all programming deliverables of a study

• Ability to work in team environment with emphasis on internal team management

• Ability to support multiple assignments with challenging timelines under direct supervision by the programming project lead or programming group head

• Excellent written and good verbal communication skills in an English global environment

• Problem solving skills that demonstrate initiative and motivation in a global collaboration environment

• Ability and mindset to embrace change, innovate and continuously improve programming practice

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