Logo of Huzzle

Home

Matches

Explore

Manage

Principal Stats Programmer (Early Phase)

image

Sanofi

3mo ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Hyderabad, +1

AI generated summary

  • You need 5-8 years in clinical data programming, advanced R/SAS skills, knowledge of early phase trials, good communication, problem-solving abilities, and a relevant degree.
  • You will program statistical deliverables, perform quality control, review study documents, create specifications for datasets, support eSub preparation, ensure compliance, and collaborate with teams.

Requirements

  • Experience: 5 to 8 Years of experience in programming preferably in processing clinical trial data in the pharmaceutical industry
  • Knowledge about early phase clinical development programs
  • Soft Skills & Technical Skills: Advanced technical skills in statistical programming, with advanced knowledge in R (and SAS), and R Shiny, 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
  • 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.
  • Language: Excellent written and good verbal communication skills in an English global environment

Responsibilities

  • 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, Transparency (Eudract, CTGov, Lay Summary), Statistical Surveillance, 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 support to the preparation of eSub package relative to HA questions, DALA, or TQT waivers.
  • Ensure compliance to SOP’s, standards, and guidelines.
  • Collaborate with study statistician and PPL on SAP, analyses and with data management team on data issues.

FAQs

What is the main role of a Principal Statistical Programmer at Sanofi?

The main role is to plan and execute high-quality and timely statistical programming deliverables within early development studies, acting as the Programming Study Lead with limited direction from the Programming Project Leader.

What are the primary responsibilities of this position?

The primary responsibilities include performing programming activities for statistical deliverables, conducting quality control, reviewing study documents, writing programming specifications, ensuring compliance with SOPs, and collaborating with the study statistician and data management team.

What kind of experience is required for this job?

Candidates should have 5 to 8 years of experience in programming, preferably in processing clinical trial data within the pharmaceutical industry, along with knowledge of early phase clinical development programs.

What technical skills are necessary for this position?

Advanced technical skills in statistical programming, with significant knowledge in R (and SAS), R Shiny, and a thorough understanding of relational databases and CDISC data structure requirements are essential.

What educational background is required for this role?

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

What are the key soft skills expected from candidates?

Key soft skills include proven communication and coordination skills, the ability to handle multiple assignments with challenging timelines, problem-solving skills, and the capacity to embrace change and innovate.

Is knowledge in specific therapeutic areas required?

While not explicitly required, having experience or knowledge across multiple therapeutic areas is beneficial for this role.

What language skills are necessary for this position?

Excellent written and good verbal communication skills in English are essential for effective collaboration in a global environment.

What benefits are offered to employees in this role?

Employees can expect a wide range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, parental leave, and a supportive work environment focused on career growth.

Will the Principal Statistical Programmer be involved in international collaborations?

Yes, the role involves working within an international team, engaging in global collaborations and contributing to data integration and visualization solutions.

image

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.