Ecron Acunova combines the strengths from two expert CROs on two continents serving established clinical research geographies. This entity is lead by Ecron’s experience of more than 20 years, strengthened by the reputed CRO Acunova. This integration enabled the two expert CRO’s to increase the value to sponsors with patient recruitment in India, West Europe and East Europe and data management from India and Europe with faster patient enrolment in clinical trials, timely database lock, high quality early phase development as well as unique features like access to the central lab for clinical trial testing.
Post: Biostatistician
Job Description:
Provide statistical input and sample size calculations during protocol design
Provide statistical inputs for CRF design and review
Generate randomization lists
Prepare statistical analysis plans for BA/BE studies
Perform data analysis
Provide Stat training to SAS programmers and knowledge sharing to statisticians
Prepare integrated summaries of regulatory queries
Understand and comply with all SOPs
Perform statistical analysis of data obtained from clinical, bioavailability, bioequivalence and other pharmacokinetics studies.
Prepare Statistical Reports based on the results obtained from statistical analysis.
Record any deviations from the protocols and SOPs.
Record raw data as per the in-house SOPs and GLP principles.
Generate random number for subject chromatograms for regulatory submission.
Generate random samples for Incurred sample stability.
Generate random samples for Case Report Form (CRF)
Candidate Profile:
Qualifications – M.Sc (BIOSTATISTICS)
Experience 2 to 4 Years
Additional Information:
Qualification: M.Sc
Experience: 2-4 years
Location: Bangalore
Industry type: Biotech
If you are interested, Please send your CV to malathi.anupoju@harneedi.com
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