Principal Biostatistician-Clinical Statistics

Sanofi

2 - 6 years

14 - 19 Lacs

hyderabad

Posted:3 days ago| Platform:

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Skills Required

sap sas clinical development clinical trials statistics workday drug safety operational efficiency protocol development pharmacovigilance peci clinical research picof clinical study report regulatory guidelines advanced statistical eib

Work Mode

Work from Office

Job Type

Full Time

Job Description

Major Responsibilities:

Support the clinical study design (including protocol development), the study setup and conduct.
Conduct the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables)
Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure
Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of statistical analyses.
Review and examine statistical data distributions/properties
Ensure productive collaborations with other functions in the aligned study team and/or safety monitoring team and in communicating with senior leadership.; Promoting teamwork, quality, operational efficiency, and innovation.
Represent statistics to participate in scientific or technology working groups or cross function initiatives

About you

Experience: Pharmaceutical or related industry experience with clinical trials.
Soft skills: Demonstrated interpersonal and communication skills.
Good knowledge and good understanding of statistical concepts and techniques
Good knowledge of pharmaceutical clinical development
Technical skills: Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
Education: MS or PhD degree in Statistics or relevant fields
Languages: Highly effective communication in English, both oral and written.

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