Senior Statistical Leadership Role

3 weeks ago

Hyderabad, Telangana, India beBeeBiostatistician Full time

Job Opportunity

Provide expert support and leadership to ensure the scientific integrity of clinical development projects. Develop advanced biostatistics methods to validate conclusions. Provide statistical expertise for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries.
Key Responsibilities:
  • Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials. Perform these tasks for high complexity trials with a high level of independence, seeking peer input/review as required. Contribute to protocol development, statistical analysis plan, and reporting activities.
  • Provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. Lead interactions with external review boards/ethics committees, external consultants, and other external parties.
  • Represent Biostatistics in cross-functional teams for assigned trials. Ensure functional alignment and awareness throughout the trials. Collaborate with other line functions.
  • Establish and maintain working relationships and effective communication within the clinical trial team and Biostatistics team. Oversee Biostatistics resources and deliverables for assigned trials.
  • Project Level- Responsible for strategic statistical input and influence into one or more projects. May be a core member of one or more early project teams representing Biostatistics.
  • Collaborate with clinical, regulatory, and other strategic functions to drive quantitative decision making in drug development. Facilitate seamless transition of projects from early to late development.
  • Disease Area / TA/Indication level: Drive strategic statistical input and excellence to development programs within assigned TA/DA/indications. Lead initiatives at global line function level or cross-functional Franchise level, requiring coordination of diverse team members.
  • Identify, evaluate, and promote innovative methods through scientific collaborations, publications, and presentations.
  • Chair sessions at professional meetings. People Management: Develop and mentor statisticians. Recruit, retain, and professionally develop up to 8 biostatisticians.

Requirements-

  • MS (Statistics) with 10+ years relevant work experience or PhD (Statistics) with 6+ years relevant work experience.
  • Fluent English. Strong interpersonal and communication skills bridging scientific and business needs.
  • Effective utilization of innovative statistics and analytics to influence decisions and support objectives. Proven knowledge and expertise in statistics and its application to clinical trials.
  • Strong understanding of drug development and Health Authority guidelines. Expert scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy.
  • May have proven people leadership ability. Demonstrated skills in building partnerships and collaborations.

Why Us: Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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