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15 Sep 2021

Temporary Senior Principal Statistician (21-28201)

iris.chen@axelon.com West Chester, Pennsylvania, United States

Job Description

Long Term Contract for a Senior Principal Statistician
Remote for Covid, then onsite in West Chester, PA

No Corp. to corp. or 3rd party.
****The Senior Principal Statistician position is for a skilled statistician with training and experience in drug development and clinical research. He or she is expected to provide statistical support to clinical studies or programs within client Global R&D. The support includes, but not limited to, strategic planning, study designs, data analyses, and regulatory interactions. He or she is expected to have extensive knowledge about statistical principles and appropriate software and tools to perform his or her tasks. A Senior Principal Statistician should be a strong individual contributor, beginning to demonstrate leadership qualities and creative and strategic thinking and capable and committed to developing over time into a leadership role. He or she must have excellent written and oral communication skills and demonstrate the ability to successfully working in a global environment.

Travel Requirements: Low

Essential Duties & Responsibilities:
1. Responsible for statistical aspect of study designs and data analyses for non-clinical/clinical studies
2. Provides study design input and consultation for clinical endpoint assessments and sample size planning
3. Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with key stakeholders, as deemed necessary
4. Writes, or oversees the writing of, statistical analysis plans
5. Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of client products
6. Leads the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses and regulatory responses.
7. Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate
8. Proactively assesses and identifies processes that require improvement
9. Participates in department initiatives to further the effectiveness of global statistics
10. Implements innovative and cutting-edge clinical trial design, methodology and analysis

Position Requirements:
Education Required: Ph.D./MS in Statistics/Biostatistics (or related field)
Experience Required: Ph.D. with a minimum of 3 years of related experience or MS with a minimum of 6 years of related experience
Experience Preferred:
Specialized or Technical Knowledge Licenses, Certifications needed:
Functional Knowledge:
Company/Industry Related Knowledge:

Job-Specific Competencies:
1. Excellent presentation and written communications skills
2. Ability to communicate with non-statisticians to interpret statistical findings
3. Excellent organizational and problem-solving skills
4. Demonstrated project and technical leadership qualities, and creative and strategic thinking required
5. Ability to program using SAS, knowledge of R is beneficial
6. Knowledge of relevant ICH, FDA and CHMP guidelines
7. Ability to mentor junior staff

How to Apply

Please share Resumes to Iris.chen@axelon.com to apply.

Job Types: Temporary.

Job expires in 33 days.

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