Bio Statistician

Clinovo is currently seeking a Biostatistician
for one of our clients.

TITLE: Biostatistician

LOCATION: Hybrid / Hyderabad / Bangalore

What you will be doing:
Provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for discovery, manufacturing, research, development, and/or marketed product needs. Activities associated with these services require varying levels of guidance from functional managers and project statisticians.
†Specific for CDSA – Data Analysis Standards focus area:

• The service holder is responsible to develop and maintain standard statistical requirements in data analysis tools and templates, compliant to industry standards and health authority regulations. Standard statistical requirements are aligned with therapeutic area / disease area needs as well as study design considerations. Examples of standard statistical requirements include:
• Standard text, definitions, and analysis requirements that are included in the Protocol and Statistical Analysis Plan
• Standard tables, listings and graph mock displays along with detailed analysis requirements and standard analysis rules included in the Data Presentation Specifications

Education and Experience Requirements:

• Master's or PhD Degree in Statistics or related field.
• Relevant Work Experience:
• Level II Advanced: minimum of 3 years for PhD and 5 years for Masters
• Level III Expert: minimum 6 years for PhD and 8 years for Masters

• Expertise in SAS or R programming.
• Level II Advanced: proficient in SAS or R
• Level III Expert: expert in SAS or R

• Good written, oral, and interpersonal communication skills.
• Specific for CDSA – Data Analysis Standards focus area:
• Only Advanced and Expert work experience levels are relevant for this focus area; however, knowledgeable in SAS or R is acceptable
• Working knowledge of relevant regulatory requirements related to analysis and reporting (eg, GCP, ICH) and of industry standards (eg, ADaM) is required
• Relevant operational experience in analysis standards is preferred.