Study Lead Programmer

Job description

Job Summary

Plan and execute high quality and timely statistical programming deliverables within a late phase study or an early phase project. Contribute to department standards, processes, tools and guidelines.

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 feedback 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) 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

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.