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Principal Stats Programmer-Safety Programming

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Sanofi

6d ago

  • Job
    Full-time
    Senior & Expert Level
  • Data
    Research & Development
  • Hyderabad, +1
    Remote

AI generated summary

  • You should have programming experience in clinical trials, advanced skills in R and SAS, knowledge of regulatory requirements, strong planning abilities, and excellent communication skills in English.
  • You will execute statistical programming tasks, conduct safety data analyses, develop programming specifications, build integrated safety databases, and collaborate with project teams to ensure quality and compliance.

Requirements

  • Experience: Programming experience preferably in processing clinical trial data in the pharmaceutical industry
  • Excellent knowledge of Good Programming Practices. Advanced technical skills in statistical programming, with advanced knowledge in R (and SAS), and R Shiny
  • Knowledge on regulatory requirement evolution; thorough understanding of pharmaceutical clinical development (i.e. statistical concepts, techniques and clinical trial principles). Ideally, have a first experience in multiple therapeutic areas.
  • Soft and technical skills: Ability to plan and perform the preparation, execution, reporting and documentation of all programming deliverables.
  • 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 safety statistical programming project leader.
  • 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.
  • Education: Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.
  • Languages: Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with colleagues across geographical locations.

Responsibilities

  • Plan and execute high quality and timely statistical programming deliverables in the context of safety center of excellence (Integrated database, safety data analyses for safety monitoring team and DSUR deliverables).
  • Perform programming activities for all statistical programming deliverables on aggregate safety analyses across trials & INDs; with associated quality control (propose to the Safety statistical Programmer Leader the validation plan and completes the associated documentation: Validation plan and quality control (QC) documentation), ensuring quality, timelines, technical validity, and compliance to internal standards, SOPs and regulatory requirements.
  • Review and provide feedbacks on Aggregated Safety Analysis Plan (ASAP) document.
  • Participate to the kickoff meeting between project team and Safety CoE.
  • Write and provide the programming specifications for the SDTM and ADaM for the integrated database, following the standard and specifications of the project mentioned by the project team.
  • Build the Integrated Safety SDTM & ADaM Database (with associated metadata and programs), following the semi-automation tool.
  • Set-up the safety data visualization analyses for each project, based on the project specifications.
  • Collaborate with safety statistician and safety statistical project leader, and with project team in the aligned project team to achieve project goals.

FAQs

What is the job title for this position?

The job title for this position is Principal Stats Programmer.

Where is this job located?

This job is located in Hyderabad, India.

What are the main responsibilities of the Principal Stats Programmer?

The main responsibilities include planning and executing statistical programming deliverables, performing programming activities for safety analyses, writing programming specifications for SDTM and ADaM, collaborating with safety statisticians, and more.

What qualifications are required for this position?

A Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related field is required.

What programming skills are essential for this role?

Advanced technical skills in statistical programming with expertise in R (and SAS), as well as R Shiny, are essential for this role.

Is experience in the pharmaceutical industry required?

Yes, programming experience in processing clinical trial data in the pharmaceutical industry is preferred.

What soft skills are necessary for this position?

Important soft skills include problem-solving abilities, capability to work in a team environment, and the ability to support multiple assignments under challenging timelines.

Are there opportunities for career growth?

Yes, the company offers endless opportunities to grow your talent and drive your career, including promotions and lateral moves.

What benefits are provided to employees?

Employees enjoy a comprehensive rewards package, including health and wellbeing benefits, high-quality healthcare, and at least 14 weeks of gender-neutral parental leave.

How does this role contribute to global health improvements?

This role involves leading the execution of high-quality safety analytics and driving innovation, which contributes to global health improvements.

Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.