Hyderabad, IND
1 day ago
Biostatistician Technical Expert - Clinical Statistics
**Main responsibilities:** + Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct. + Conduct / Oversee the execution of the statistical analyses according to the SAP and ISAP, 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. + Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization. Provide mentoring and coaching advanced statistical methodologies to junior statisticians in Hub. + Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis. + Accountable for all assigned statistical deliverables related to multiple studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands 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. + Coordinate with study programmer the production and Qc of statistical analyses. + Contribute to operation process optimization and provide inputs to statistics and quality standards. + Represent statistics team to participate in scientific or technology working groups or cross function initiatives. + undefined **Experience** :(MS) or (PhD) of solid pharmaceutical industry experiences.Experience of project management and development preferred. **Soft and technical skills** :Broad knowledge and good understanding of advanced statistical concepts and techniquesDemonstrated strong project/study management, interpersonal and communication skills.Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiencesExtensive ability to apply advanced statistical analyses using SAS and R languages.Knowledge or experience with Artificial intelligence or Generative AI is a plus **Education** : MS or PhD degree in Statistics or relevant fields **Languages** : Highly effective communication in English, both oral and written. **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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