Mumbai, MH, in
6d ago

Job Description


Graduate / Post-Graduate in Statistics / Mathematics / Computer Science / Life Sciences.

A minimum of 4 years of total experience with a at least 2 years of experience in Statistical programming

and / or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or

Pharmaceutical or Biotechnology company

Thorough knowledge of the pharmaceutical industry including understanding of clinical drug

development process and associated documents and regulations.

Good knowledge of GCP, Good Programming Practices, ICH-E3, I CH-E9 and other regulatory guidance

documents (e.g. USFDA and EMEA)

Understanding client’s requirement and providing all the required statistical inputs on , SAP, Mock

Shells, Tables, Listings, Figures or any other statistical programming deliveries

Good understanding of the statistical programming domain and related processes

Assists with developing, monitoring, and enforcing productivity and quality standards along with

related documentations

Coordinating with the project management in meeting the timeline and defining / capturing the

metrics for monitoring and maintaining the quality and productivity

Good verbal and written communication skills coupled with good organizational skills

Technical :

Strong Analytical and programming Skills using statistical software SAS or equivalent with

understanding of development and / or execution of SAS macros

Knowledge of R will be an added advantage

Should have worked on generating and validating tables, listings and figures

Should have worked on Derived datasets / Analysis Datasets / ADaM / SDTM

More complex review (programs with high risk)

Programming and review of outputs for DSUR, PSUR, publications

Exposure on Exploratory analyses is an added advantage

Programming and review of analysis data sets.

Provide training and guidance to lower level and new staff .

Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports)

Compliance :

  • Adherence to SOPs and GPP
  • Q uality and adherence to timelines.

    Self-motivation and self-learning

    Achievement orientation

    Relationship building ability

    Inclination towards being process driven


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