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Stats Programmer (Vaccine)

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Sanofi

Yesterday

  • Job
    Full-time
    Junior Level
  • Data
    Research & Development
  • Hyderabad, +1

AI generated summary

  • You should have 2+ years in clinical statistical programming, vaccine experience, SAS skills, CDISC SDTM/ADaM knowledge, teamwork, organization, and critical thinking capabilities.
  • You will program statistical deliverables, review study documents, ensure compliance with CDISC standards, and contribute to quality control and integrated clinical database programming.

Requirements

  • Experience: Should Have at 2 + Years of experience in clinical statistical programming.
  • Should Have experience on vaccine therapeutic area in clinical statistical programming.
  • Soft Skill & Technical Skill: technical skills in SAS/BASE, STAT, MACRO
  • Experience on programming CDISC SDTM/ADaM datasets according to existing specifications (including running and resolving P21 compliance checks) is must.
  • Ability to work according to existing specifications.
  • Demonstrate an understanding of processes associated with clinical trials and statistics.
  • Demonstrate interpersonal skills necessary for effective teamwork.
  • Demonstrate ability to organize multiple work assignments and establish priorities.
  • Demonstrate critical thinking skills beyond simply following directions or specifications

Responsibilities

  • Perform programming activities for all statistical deliverables (i.e.: SDTM, ADaM, Tables Listings and Figures (TLF)) for various analyses within a study (e.g.: interim/final analyses, internal or external data monitoring committees, statistical surveillance)
  • Review and provide feedback on study documents such as Case Report Form, Statistical Analysis Plan (SAP), mock TLFs, programming specifications
  • Write or review programming specifications for the SDTM/ADaM/TLFs to fulfil the study objectives
  • Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations
  • Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)
  • Contribute to quality control for statistical programming deliverables and complete the associated documentation
  • Might contribute to core integrated clinical database programming, pooling across several studies within an asset
  • Ensure compliance to SOP's, standards, and guidelines.

FAQs

What is the main focus of the Stats Programmer role at Sanofi?

The main focus of the Stats Programmer role is to deliver biostatistics and programming activities throughout the Vaccines R&D value chain, which includes PreClinical, Clinical, Translational, and CMC.

How many years of experience is required for this position?

A minimum of 2 years of experience in clinical statistical programming is required for this position.

Is experience in the vaccine therapeutic area mandatory?

Yes, experience in the vaccine therapeutic area is a requirement for this position.

What programming skills are necessary for this role?

Technical skills in SAS/BASE, STAT, and MACRO are necessary for this role.

What is the expectation around CDISC data packages?

The candidate must deliver a compliant CDISC data package with all relevant documentation, fulfilling Health Authorities' expectations.

Will the candidate be responsible for programming specifications?

Yes, the candidate will be required to write or review programming specifications for SDTM/ADaM/TLFs to fulfill the study objectives.

What type of analyses will the programmer perform?

The programmer will perform programming activities for various analyses within a study, including interim/final analyses and statistical surveillance.

Are there opportunities for teamwork in this role?

Yes, the role requires effective interpersonal skills necessary for teamwork and collaboration within the Vaccines Global Biostatistical Sciences team.

What kind of documentation will the programmer need to contribute to?

The programmer will need to contribute to documentation such as aCRF, reviewers guide, and define.xml, as well as ensuring compliance with SOPs, standards, and guidelines.

Are critical thinking skills important for this position?

Yes, demonstrating critical thinking skills beyond simply following directions or specifications is an important requirement for this position.

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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.