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2454 - Principal BioStatistician - Oncology Late Phase Studies (Remote, US or Canada)

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Date: Nov 19, 2020

Location: Denver, CO, US Denver, CO, CA Denver, CO, CA

Company: Cytel Inc

<span style="font-family:"Arial",sans-serif">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.


<span style="font-family:"Arial",sans-serif">The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:


  • <span style="font-family:"Arial",sans-serif">Providing statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level with complex programs
  • <span style="font-family:"Arial",sans-serif">Promoting innovative design and efficient analysis methodology.
  • <span style="font-family:"Arial",sans-serif">Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
  • <span style="font-family:"Arial",sans-serif">Improving and using standards to maximize global data integratability, interpretability and compound level efficiency
  • <span style="font-family:"Arial",sans-serif">Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.
  • <span style="font-family:"Arial",sans-serif">Independently representing Statistics function in interactions with regulatory authorities on study design and submissions.


<span style="font-family:"Arial",sans-serif">ACCOUNTABILITIES: 

  • <span style="font-family:"Arial",sans-serif">Actively participate in and contribute to decision making related to clinical development strategies, regulatory strategies, and commercial strategies.
  • <span style="font-family:"Arial",sans-serif">Promote innovative design and analysis methodology
  • <span style="font-family:"Arial",sans-serif">Provide statistical leadership in design, analysis, and interpretation of clinical studies at a compound level with large complex programs.
  • <span style="font-family:"Arial",sans-serif">Independently represent statistics function on global <span style="font-family:"Arial",sans-serif">teams in support of clinical studies and compound level programs.
  • <span style="font-family:"Arial",sans-serif">Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions. Negotiate timelines (statistical) at compound level.
  • <span style="font-family:"Arial",sans-serif">Plays a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
  • <span style="font-family:"Arial",sans-serif">Oversee definition and implementation of compound-level database (including derived database), analysis and reporting standards.  Improve or use existing standards to ensure maximization of global integrability and interpretability of data and enhance efficiency at compound level.  Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at compound level.
  • <span style="font-family:"Arial",sans-serif">Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
  • <span style="font-family:"Arial",sans-serif">Identify compound level vendor requirements and participate in the evaluation/selection of vendors. Provide compound level analytical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
  • <span style="font-family:"Arial",sans-serif">Identify and interact with external statistical experts for issues related to study design, methodology and results.
  • <span style="font-family:"Arial",sans-serif">Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program.  Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
  • <span style="font-family:"Arial",sans-serif">Lead the implementation of department standards and process improvements.
  • <span style="font-family:"Arial",sans-serif">Lead evaluation and implementation of alternative analysis methodology and data presentation techniques.
  • <span style="font-family:"Arial",sans-serif">Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods and implement innovative approaches at a compound level.


<span style="font-family:"Arial",sans-serif">EDUCATION, EXPERIENCE AND SKILLS: 

  • <span style="font-family:"Arial",sans-serif">Master’s or PhD in Statistics or Biostatistics with at least 5 years of experience supporting clinical drug trials for Oncology products
  • <span style="font-family:"Arial",sans-serif">Experience with global regulatory submissions
  • <span style="font-family:"Arial",sans-serif">Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
  • <span style="font-family:"Arial",sans-serif">Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
  • <span style="font-family:"Arial",sans-serif">Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
  • <span style="font-family:"Arial",sans-serif">Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Excellent oral and written communications skills.
  • <span style="font-family:"Arial",sans-serif">Strong SAS programming skills.
  • <span style="font-family:"Arial",sans-serif">Strong project management skills.
  • <span style="font-family:"Arial",sans-serif">Strong collaborative skills and ability to work with a cross-functional team.
  • <span style="font-family:"Arial",sans-serif">Experience with exploratory/clinical biomarkers.

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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