Job Description

Review Scientific and business requirements to propose appropriate and efficient statistical designs for clinical studies, both premarketing and post marketing including the calculation of sample sizes conciliating the need to provide valid results with those of keeping a reasonable study size.

Helps in the interpretation of scientific literature, notably in aspects relating to its numerical validity, limitations and in the adaption of the results for use in study design and general decision making. Supporting in preparation of clinical scientific meeting requirements.

Conduct clinical trial simulations to optimize the selection of clinical trial endpoints, statistical analysis methods and clinical trial design.

Provide expertise and guidance in clinical study design and implement efficient and effective practices in the execution and analysis of clinical trials.


Preparation and review of relevant statistical sections of Clinical trial outline document and protocols.

Review of Case Report Forms (CRF) /eCRF.

Review of other data management related documents.

Review and providing inputs for Clincial study report for statistical conclusions and interpretations.

Collaborate effectively with internal and external teams to support and resolve the statistical issues.

Preparation and Review of Randomization plans.

Review of dummy randomization and IWRS/IVRS guidelines.

Preparation and review of Statistical Analysis Plans(SAP).

Providing statistical support in analyzing the data as per SAP.

Review and preparation of mock Tables, Listings and figures.

Providing inputs for Data Cleaning and assisting data clean meetings.

Preparing and reviewing Blinded Data review (BDRM/DRM) rules and setting up meetings to finalize the analysis populations.

Oversee of statistical analysis programming, validation and analysis of clinical trials.

Review of Key TFL and providing summaries on key study outcomes.

Oversee, review and finalization of of study tables, listings and figures.

Performe Interim analysis and review of sample size re-estimations.

Provides statistical analyses for decision making, regulatory submissions and interactions with regulatory agencies.

Interpreting the results and and presenting the results and summaries.

Prepares reports that summarize the analysis, interprets the findings and provides conclusions and recommendations including statistical analyses for decision making, regulatory submissions and resolving regulatory queries.

Review of SDTM and ADaM as per CDISC standards.



Mandatory Skills


knowledge of SAS, R and other relevant statistical software's. Understanding data management principles for clinical trials and medical research. in depth understanding of statistical theory and modeling. strong analysis and interpretation skills.

Strong knowledge of statistics including experimental and clinical trial design, linear and mixed statistical models, non-parametric statistics, logistic and poison regression, longitudinal data analysis, and categorical data analysis. Therapy Areas; Diseases; Treatment options; Technology Platforms, Delivery systems, basics of clinical development







Qualifications

MAsters in Statistics/Biostatistics

Additional Information

Close to 15 years of experience in Pharma industry handling clinical trials