Required Skills

Java management skills Statistical Analysis Plan dataset specifications

Work Authorization

  • US Citizen

  • Green Card

  • EAD (OPT/CPT/GC/H4)

  • H1B Work Permit

Preferred Employment

  • Corp-Corp

  • W2-Permanent

  • W2-Contract

  • Contract to Hire

  • Need H1B

Employment Type

  • Consulting/Contract

education qualification

  • UG :- - Not Required

  • PG :- - Not Required

Other Information

  • No of position :- ( 1 )

  • Post :- 3rd Oct 2023

JOB DETAIL

Include but are not limited to:

  • Provide quality deliverables by following corporate and departmental policies, procedures and applicable standards.
  • Perform data manipulation, analysis and reporting of clinical trial data.
  • Create analysis files, tables, listings, and figures and validation of those files.
  • Maintain project tracking and validation documentation.
  • Work well in an environment where team members may be distributed across multiple locations.
  • Review planning documents (Statistical Analysis Plan, dataset specifications, etc.) to ensure project objective alignment, clarity, accuracy and completeness of programming requirements.
  • Present statistical programming concepts to non-programming team members as necessary
  • Collaborate effectively with cross-functional teams and interface with multiple stakeholders to manage timelines and priorities.
  • Serve as back-up to Principle Statistical Programmer as needed.

Basic Qualifications

  • BA/BSc in Statistics, Mathematics, Computer Science, Life Sciences or other related scientific subject with at least 8 years of relevant experience or Master’s degree and at least 6 years
  • Prior regulatory submission and response experience
  • Excellent analysis and reporting skills
  • Command of drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data
  • Knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards.
  • Ability to work effectively and successfully in a dispersed team environment with cross-cultural partners.
  • Excellent oral and written English communication skills.
  • Excellent time management skills, able to meet required timelines.
  • Ability to provide quality output and deliverables, in adherence with timelines.
  • Willingness and ability to learn and follow standard processes and procedures.

Preferred Qualifications

  • Familiarity with other programming languages (e.g. Java, R, or S-Plus)
  • In depth knowledge of SAS Graph and Stat packages

 

 

Company Information