Senior Biostatistician

About Saarthee:

Saarthee is a Global Strategy, Analytics, Technology and AI consulting company, where our passion for helping others fuels our approach and our products and solutions. Our diverse and global team work with one objective in mind: Our Customers’ Success. At Saarthee, we are passionate about guiding organizations towards insights fueled success. That’s why we call ourselves Saarthee inspired by the Sanskrit word ‘Saarthi’, which means charioteer, trusted guide, or companion. Cofounded in 2015 by Mrinal Prasad and Shikha Miglani, Saarthee already encompasses all the components of Data Analytics consulting. Saarthee is based out of Philadelphia, USA with office in UK and India.

Position Summary:

R Programming

Your Role Responsibilities and Duties:

• Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines.
• Perform efficacy analyses using R programming.
• Work independently on studies and support clinical trial submissions.
• Collaborate with cross-functional teams in an FSP environment.
• Debug and utilize standard macros efficiently.
• Preferred involvement in integrated summaries (ISS/ISE).

Required Skills and Qualifications:

• 6 to 8 years of relevant experience in statistical programming

• Minimum 3 years of hands-on experience with R programming.

• Strong knowledge and working experience with

  CDISC standards: SDTM, ADaM, and TLF.

• Exposure to

  efficacy analysis

  .
• Study-level handling experience (for senior-level profiles).

Preferred Skills:

• Experience with

  CRT package (Trial Data Domain).

• Prior involvement in

  ISS and ISE

  .
• Experience in an

  FSP environment

  .
• Familiarity with

  standard macro debugging and utilization.