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Sr Program Manager, Biostatistics

North Wales,North Carolina,Texas
Reference: JR061922

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

The Sr. Program Manager, BioStats is responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on assigned studies of moderate complexity, ensuring individual studies are delivered on time, on budget to required quality.

The role

  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Accountable for the Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact
  • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
  • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission This includes ensuring activities are of high quality, within budget and on time completion and maintaining a consistent approach across studies.
  • Liaises regularly with biostatistics/programming study/program leads to ensure support on key discussions (timelines…etc.) and early warning to senior management of programming issues (resource/project issues...etc.)
  • Liaises regularly with the programming program lead to ensure program level programming solutions are being identified and implemented.
  • Ensures that all work is carried out in accordance with ICON SOPs. Develops program specific procedures (SSPs) as required and ensures that team members adhere to the SSPs.
  • Establishes and maintains effective working relationships with clients and ICON project team members, including data management personnel, statistical programmers, and clinical research personnel.
  • Participates in presentations at client and investigator meetings.
  • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client.
  • Ongoing coaching and mentorship of team members.
  • Embrace and lead departmental process improvement initiatives with a focus on streamlining our processes adding value to our business and meeting client needs.

What you need

  • M.S. or Ph.D. degree in statistics, biostatistics, or related field.
  • 8 years or more experience in a CRO or Pharmaceutical environment
  • Excellent verbal and written communication skills are required.
  • Knowledge in applied parametric and nonparametric statistics and SAS programming skills.
  • Should be able to translate clients' needs into statistical practice and educate clients in the use of statistic

Why join us?

Ongoing development is vital to us, and as a Sr. BioStats Program Manager you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success!

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin


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