Senior Associate, Senior Statistical Data Scientist

IND - Mumbai, India

Apply now Apply later

ROLE SUMMARY

  • A productive, hand on programmer who applies technical knowledge of CDISC and practical experience to deliver statistical programming deliverables leveraging CDISC constructs: SDTM, ADaM, and Control Terminology
  • Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible
  • Ensures adherence to high quality programming standards in their daily work

ROLE RESPONSIBILTIES

  • Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas:  CDISC , ADaM, and TLF generation.
  • Demonstrate experience working as part of a software development team and fundamental SDLC processes.
  • Ensures excellence in the understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible.
  • Ensures adherence to Pinnacle 21 CDISC validation checks and high-quality programming standards in their daily work.
  • Exhibits routine and occasionally complex problem-solving skills, seeking direction when appropriate.
  • Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.
  • Will be knowledgeable of software development practices as defined within Pfizer’s CDISC development framework.
  • May contribute to department level initiatives.

QUALIFICATIONS

  • Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field
  • At least 5 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
  • Statistical Programming and SAS hand-on experience
  • Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
  • Good understanding of ICH and regulatory guidelines
  • Working knowledge of clinical data and relevant data standards
  • Strong written and oral communication skills, and project management skills
  • Proven ability to operate with limited oversight.
  • Knowledge of at least 1 Therapeutic Area
  • Proven ability to manage delivery under tight timelines.
  • CDISC experience require.
  • Pfizer CDARS experience desirable.

  
Work Location Assignment: Flexible

  
Work Location Assignment: Flexible
  
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

#LI-PFE
Apply now Apply later

* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰

Job stats:  0  0  0
Category: Data Science Jobs

Tags: CDISC DataOps Pharma SAS SDLC Statistics

Perks/benefits: Flex hours

Region: Asia/Pacific
Country: India

More jobs like this