Principal Biostatistician, DMC

Date: Jan 5, 2023

Location: US

Company: Cytel Software Corporation

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.

 

We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I –IV clinical studies across a variety of therapeutic areas.  If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!

 

 

The Principal Biostatistician leads teams of biostatisticians and statistical programmers in creating unblinded reports of confidential, ongoing clinical trial data for DMCs. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.

 

Responsibilities:

  • Implements a wide variety of statistical methodologies
  • Presents statistical reports to DMCs and clients.
  • Provides guidance and oversight of biostatistics and programming teams in production of statistical analyses and reports, including interim analyses and adaptations, for DMCs.
  • Ensures blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related SOPs and regulatory requirements.
  • Serves as primary contact for clients and DMCs.
  • Hosts DMC meetings and presents unblinded reports to the DMC in closed meeting sessions.
  • Leads and facilitates project team meetings on a regular basis.
  • Develops and facilitates internal and external presentations, as appropriate.
  • Interact and coordinate with non-DMC Cytel functional groups.

 

Qualifications:

  • Master’s degree or PhD in Biostatistics, Statistics, or related field.
  • 3 years’ experience working with clinical trial data, preferably in a CRO environment.
  • Expert level knowledge of statistical concepts with working knowledge of medical/scientific terminology
  • Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
  • Must read, write and speak English.
  • Prior DMC experience required.

 

Physical, Mental & Sensory Requirements:

 

Ability to use computer keyboard/mouse; sit for long periods; see computer monitor and read; speak and listen.  Occasional long hours, and/or weekend/holiday hours.  75% of time spent at computer. Long and short term travel may be required, sometimes on short notice.

 

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.