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Sr. Director Clinical Statistics

Job Location: PA - Berwyn

Job Number: 00459964

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- Job description

People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.

 

Job Description

 

The Senior Director Clinical Statistics will develop and lead the Clinical Statistics department and provide statistical consultancy to clients in the life sciences. Clients include companies developing applications in the areas of specialty pharmaceuticals, devices, and biotechnology.


Key Responsibilities:

  • Lead Data Monitoring Committee activities as an independent and a DMC Statistician.
  • Perform clinical trial design, sample size determination, preparation of randomization schedules, statistical analysis, interpretations of statistical results, and preparation of statistical sections for clinical study reports.
  • Evaluate and recommend appropriate statistical methods for data analysis.
  • Provide support for submission applications being sent to regulatory authorities.
  • Give advice to clients in all dealings with statistical issues as they pertain to submission and approval activities during the entire life cycle of product development.
  • Support post marketing strategy and implementation providing leadership in assuring quality for all statistical deliverables.
  • Develop and mentor staff

 

 

Basic Qualifications

  • Master's degree in Statistics/Biostatistics
  • Minimum 12 years' pharmaceutical industry experience with expertise in statistical analyses and design of clinical trials across multiple statistical methodologies

Preferred Skills

  • PhD. degree in Statistics/Biostatistics
  • Supervisory/staff management/leadership experience
  • Development of statistical analysis plans
  • Understand CDISC standards and Adam Data Structure
  • Thorough knowledge of regulatory submission process
  • Experience interacting (direct or indirect) with the FDA

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

 

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

 

Accenture is a Federal Contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

 

Equal Employment Opportunity

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

 

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

 

Accenture is committed to providing veteran employment opportunities to our service men and women.

 



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