Company Info

Job Description

The Associate Director, Statistics position is for a skilled statistician with training and significant experience in drug development and clinical research.  He or she is expected to provide statistical leadership for overall program and individual study strategy within a therapeutic area. He or she needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks.   An Associate Director, Statistics must be a strong individual contributor, demonstrating leadership qualities, creative and strategic thinking and knowledge of cutting-edge clinical trial design and methodology for clinical studies. He or she must experience with regulatory submissions both in the US and outside of the US. He or she must have excellent written and oral communication skills.

Provides strategic input for study design and clinical development plan and consultation for clinical research protocols

Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with Clinical Research personnel.

Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of CNS products

Ensures that data sets and their associated define files are prepared correctly and on time to support FDA submissions

Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate

Qualifications

MA/MSc/PhD in Statistics/Biostatistics (or related field)

At least 7 years of related experience for PhD, or 10 years of related experience for MA/MSc

• Experience with regulatory submissions in the US
• Experience with regulatory submissions outside the US
• Ability to program using SAS, knowledge of R is beneficial
• Knowledge of CDISC SDTM and ADaM

Knowledge of relevant FDA and CHMP guidelines

Function

Sub Function

Reports To

Director Head Clinical Pharmacology

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