Associate Director Biostatistics

Associate Director Biostatistics

Sandoz

Holzkirchen, Germany

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Program Level:
  • Responsible for strategic statistical input and influence into one or more programs (clinical development plan, HA strategy/interactions and statistical/submission deliverables);
  • Propose and implement innovative and efficient study designs and statistical methods to optimize drug development;
  • Represent Biostatistics in cross-functional teams and be responsible for functional alignment and to internal review boards;
  • Ensure timeliness and adequate quality of all Biostatistics deliverables – whether internal or outsourced to vendors;
  • Lead or significantly contribute to clinical initiatives and mentoring programs within line function, cross-functionally or globally.
• Trial Level:
  • Responsible for all statistical tasks (Protocol, SAP, CSR etc.) for high complexity trials with a high degree of independence;
  • Provide statistical expertise to support submission activities, meetings with and responses to Health Authority requests;
  • Mentor, guide and support trial level statisticians.

What you’ll bring to the role:

Essential Requirements:

• MS or PhD (in Statistics or equivalent);
• 6+ years relevant work experience;
• PK, PD, Biomarker and Phase III trials;
• Program level, HA interaction and submission experience;
• Advanced skills in SAS and/or R statistical software;
• Fluent English (oral and written);
• Strong interpersonal and communication skills bridging scientific and business needs.

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