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
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
Preferable: Graduation in Statistics, SAS certification
Experience:
4-5 years
Skills: {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
In case you are interested kindly send us the following details-
First Name / Middle name/ Last Name
Updated CV with DOB & year of passing First and Final Graduation
Current CTC
Expected CTC
Time to ! Join
City of Birth
Scanned copy Of current company I.D.Card.Please attach with the Updated cv.
Kindly send us your detailed CV at info@cliniminds.com - please mention position title in the subject line.
