Job Description – Senior Biostatistician & Statistical Programmer

Qualification:

•     Postgraduate in Statistics, SAS certification

Experience:7-10 years

•     Preparation and Review of Statistical Analysis Plan (SAP)
•     Development of well-presented TLF Mock-shells (determination of relevant statistical methods) as per the study protocol
•     Provide statistical inputs for the clinical trial protocol
•     Determination of sample size for Phase II, III and IV clinical trials
•     Generation of randomization schedule
•     QC of Table, Listing and Figures (Efficacy and safety tables)
•     Review of SAS annotated Case Report Form as per the CDISC standards and other study documents to         ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis
•     Statistical analysis of clinical trial data
•     Coordination with other biostatistician and statistical programmer on assigned projects to ensure timely completion of high quality work
•     SAS Programming specifications for analysis datasets, Table, Listing and Figures (Efficacy and safety tables)
•     Review of Clinical study report from statistical aspects ensuring that results are captured in consistent with the analysis described in the SAP
•     Serves as biostatistics representative on project teams
•     Preparation and Review of SAS and Biostatistics related departmental SOPs

Job Description – Junior Biostatistician & Statistical Programmer

Qualification:

•     Postgraduate in Statistics, SAS certification

Experience:5-6 years

•     Preparation and Review of Statistical Analysis Plan (SAP)
•     Development of well-presented TLF Mock-shells (determination of relevant statistical methods) as per the study protocol
•     Provide statistical inputs for the clinical trial protocol
•     Determination of sample size for Phase II, III and IV clinical trials
•     Generation of randomization schedule
•     SAS Programming specifications for analysis datasets, Table, Listing and Figures (Efficacy and safety tables)
•     QC of Table, Listing and Figures (Efficacy and safety tables)
•     Review of SAS annotated Case Report Form as per the CDISC standards and other study documents to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis
•     Statistical analysis of clinical trial data
•     Coordination with other biostatistician and statistical programmer on assigned projects to ensure timely completion of high quality work
•     Review of Clinical study report from statistical aspects ensuring that results are captured in consistent with the analysis described in the SAP
•     Serves as biostatistics representative on project teams

Job Description – Statistical Programmer

Qualification:

•     Minimum: Graduation, SAS certification

Experience:4-5 years
Statistical programmer (additional biostatics experience will be an added advantage)

•     SAS Programming specifications for analysis datasets, Table, Listing and Figures (Efficacy and safety tables)
•     QC of Table, Listing and Figures (Efficacy and safety tables)
•     SAS Programming of Edit Specification Document
•     Review of Edit Specification Document
•     SAS Programming for Signal Management Activity (Pharmacovigilance)
•     QC of outputs from Signal Management Activity (Pharmacovigilance))
•     Preparation and Review of SAS and Biostatistics related departmental SOPs
•     Generation of Randomization Schedule
Optional
•     Preparation and Review of Statistical Analysis Plan (SAP)
•     Development of well-presented TLF Mock-shells (determination of relevant statistical methods) as per the study protocol
•     Review of SAS annotated Case Report Form as per the CDISC standards and other study documents to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis
•     Provide statistical inputs for the clinical trial protocol

1. First Name / Middle name/ Last Name
2. Updated CV with DOB & year of passing First and Final Graduation
3. Current CTC
4. Expected CTC
5. Time to ! Join
6. City of Birth
7. Scanned copy Of current company I.D.Card.Please attach with the Updated cv.