Director, DMC Biostatistics

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I –IV clinical studies across a variety of therapeutic areas. If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!

The Principal Biostatistician leads teams of biostatisticians and statistical programmers in support of DMCs.

Responsibilities:

• Serves as primary contact for clients and DMCs.
• Provides guidance and oversight of biostatistics and programming teams in production of statistical analyses and reports, including interim analyses and adaptations, for DMCs.
• Serves as host for DMC meetings and presents unblinded DMC reports to the DMC in closed meeting sessions.
• Attends and facilitates project team meetings on a regular basis.
• Ensures blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related SOPs.
• Adheres to SOPs and applicable regulatory requirements.
• Develops and facilitates internal and external presentations, as appropriate.

Qualifications:

• Master’s degree in Biostatistics, Statistics, or related field.
• 8+ years experience working with clinical trial data, ideally in a CRO environment.
• Expert level knowledge of statistical concepts with working knowledge of medical/scientific terminology
• Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
• Must read, write and speak English.
• Prior DMC experience preferred.

Physical, Mental & Sensory Requirements:

Ability to use computer keyboard/mouse; sit for long periods; see computer monitor and read; speak and listen. Occasional long hours, and/or weekend/holiday hours. 75% of time spent at computer. Long and short term travel may be required, sometimes on short notice.

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Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

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