CT Biostatistician / CT SAS Programmer / PK Expert

Role & responsibilities

CT Biostatistician: (Tech. Executive/Assist. Manager)

M.Sc. (Statistics), SAS Programming Certifications, 3 to 5 yrs of CRO / Pharma industry experience.

• Study statistician for late phase clinical trial
• Preparation and review of SAP (Statistical Analysis Plan) and study protocol inputs
• Blinded / Unblinded statistical roles for DSMB & BDRM meetings
• Statistical Data Analysis & Reporting
• Regulatory query response and interactions

CT SAS Programmer: (Sr. Technical Officer / Technical Executive)

M.Sc. (Statistics) or M.Pharm. with SAS Base or Advance certifications. 3+ yrs of CRO experience.

• SAS programing for Tables, Listings & Figures
• Generating CDISC deliverables (SDTM, ADaM)
• Creating SAS Viya dashboards
• Inputs for DM & RBQM activities
• Review and Validation of SAS codes & outputs

PK Expert: (Tech. Executive - PK)

M.Pharma. (Pharmacology)

3+ yrs of CRO / Pharma industry experience with Phoenix WinNonlin processing knowledge

• Early phase study feasibilities & protocol inputs
• Critical review of BABE / PK results
• Scientific inferences for PK results & investigations
• Regulatory query responses and interactions
• Technical meetings with scientific reviewers