Sr. Director, Biostatistical Consulting

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Requirements:

• Graduate degree in statistics, mathematics, life science, epidemiology, or healthcare.
• Minimum 15 years of relevant work experience, with at least 10 years in drug development or clinical research.
• Thorough knowledge of GxP and relevant regulations, including GDPR/HIPPA and CFR/CTR/CTD.
• Strong skills in SAS and/or other statistical programming languages, and proficiency with sample size software.
• Excellent communication skills, both written and verbal, with an emphasis on collaboration and client focus.

Responsibilities:

• Provide statistical consulting to sponsors to support clinical program development, protocol development, and sample size calculations.
• Lead complex statistical analyses and provide input on regulatory questions related to submissions.
• Prepare statistical analysis plans (SAPs) and review statistical documents ensuring quality and integrity.
• Act as the lead statistician on studies, manage unblinded tasks, and ensure collaboration across functional areas.
• Maintain strong relationships with clients and participate in marketing activities.