Position: Director

Job type: Full-time

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Job content

Job Summary

The Director, Biostatistics represents a key role within the Business Unit providing technical and scientific expertise, and is the primary functional interface to the client, addressing client functional concerns, and seeks to maintain a strong collaborative relationship. Also provides leadership, strategy and vision to the Biostatistics team, and uses experience level to resolve most issues and discussions close to the project team, finding efficient solutions. May serve as a subject matter expert on elements of clinical trial design and the implementation of advanced statistical methodologies.

Job Responsibilities

In a managerial capacity, responsibilities will include:
  • Engage with Client functional leads, participate in Steering Committee meetings, and adjudicate personnel issues
  • Liaise with Recruiters, Strategic Account Managers, Business Development, and Finance to ensure a strong client relationship
  • Assume responsibility for functional team objectives, budget, maintaining margins, financials for client relationship
  • direct activities across multiple project teams
  • provide growth and career development for direct reports, who may also be managers
  • works with senior management to address and find solutions for personnel issues
  • lead statistical discussions around statistical matters pertaining to clinical trial designs, methodologies, regulatory inquiries and submission strategies
  • interact with client leaders to ensure quality performance
  • perform resource planning and shifting on multi-project level
  • provide performance management to ensure a successful client relationship
  • review financial reports, budget proposals and attend bid defense meetings
  • mentor Biostatisticians
  • provide leadership for Biostatistics Group and lead initiatives

Additional Responsibilities Will Include
  • provide statistical expertise into clinical trial designs and all aspects of clinical trials
  • serve as functional lead on and across project teams
  • lead discussions with client leads
  • interact and coordinate with client staff
  • review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor

Qualifications

Education: PhD / MS in Biostatistics, Statistics, or related discipline

Experience: Relevant technical and functional leadership experience directly supporting clinical trials in pharmaceutical setting with a minimum of 4 years in a managerial role.

Skills
  • Advanced Knowledge of statistical methodology and analytic techniques
  • Ability to lead multi-project teams
  • Conversant in SAS programming and associated processes
  • Conversant in FDA and ICH regulations and industry applicable standards.
  • Conversant with aspects of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
  • Ability to handle large volume of complex tasks
  • Excellent oral and written communication skills
  • Highly motivated by team environment
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.
Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
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Deadline: 10-05-2024

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