Biostatistician Technical Expert - Clinical Statistics

As a Biostatistician Technical Expert - Clinical Statistics within our Clinical Statistics Team at Hyderabad, youll lead/oversee statistical support of a team of senior and principal biostatisticians, be accountable for statistical aspects and deliverables of the team for several early/late phase studies. Provide directions and guidance in carrying out project assignments, interacting with other internal functions and applying advanced statistical methods while ensuring scientific integrity to project work.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

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.

About you

Experience:

• 7+ years (MS) or 5+ years (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 techniques
• Demonstrated strong project/study management, interpersonal and communicationskills.
• Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences
• Extensive 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.