Statistician Manager (US/Remote)

Location: United States

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Requisition Number: 3921

Position Title: Manager, Biostatistics

External Description:

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

 

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.   

 

   Manage assigned Biostatistics operations team members, independently manage Biostatistics project support activities, provide expert consultancy / input across the statistic function and identify / sponsor process improvement initiatives within the Biostatistics function.
 
 
RESPONSIBILITIES:
Tasks may include but are not limited to:
 

  • Proactively manage the performance and professional development of assigned Biostatistics operations team member through capability assessment, performance management, resource review / planning, training / development, mentoring and disciplinary interventions to meet the needs of the business.
  • Manage the Biostatistics contributions / support to assigned projects / sponsors, ensuring timely, complete and profitable delivery of contracted services via expert statistical consultancy and support.
  • Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing of statistical sections of the study protocol.
  • Provide expert review / input to study designs, analysis and reports.
  • Develop internal relationships with other functions to ensure synergy of working practices across functions.
  • Represent the function externally by developing / managing customer relationships and attending / participating in external meetings.
  • Provide project support to the statistics reporting process through the specification / review of table, figure and listing shells, writing / review of derived dataset specifications and the formatting of report documents and tabulations.
  • Provide support to the bidding process, including contributions to budget review, proposals and bid defense meetings.
  • Lead identifying system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting / WCT process improvement / business transformation initiatives.
  • Support the development of statistical design and analysis policies.
  • Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery) and regulatory guidance documents (e.g., ICH, FDA and CPMP Points To Consider).
  • Participate in local, regional and international meetings / conferences, maintaining contemporary educational requirements / certifications / training.
  • Assist with – and contribute to - Quality Assurance audits and regulatory body inspections.
  • Assist VP / director of Biostatistics with all other aspects of the job as required.
  • Perform all activities in compliance with WCT and agreed-upon sponsor quality system standards, relevant ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).

 
 
OTHER SKILLS AND ABILITIES:

  • The job holder should have well developed consultancy and facilitation skills together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, building capability, embracing innovation and change and participative leadership.
  • The job holder should have a broad experience of developing the role of a statistician across the business including extensive experience in all phases (I to IV) of clinical research along with expert knowledge of the applicable regulatory standards.
  • At least 5 years in a senior statistical role is necessary.

REQUIREMENTS:

  • A post graduate degree in statistics with proven experience in using statistics in a clinical research environment.
  • Minimum 2 years of management experience.
  • Experienced in guiding / mentoring / managing other statisticians.

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Employment Type: Regular

Community / Marketing Title: Statistician Manager (US/Remote)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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