Director, Biostatistics

Location
San Diego, CA
Posted
Jun 06, 2022
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time

Job Summary:

The Associate Director/Director of Biostatistics at MEI Pharma is responsible for leading, developing and implementing statistical solutions to optimally support all phases of clinical trials, regulatory submissions, and decision makings. This person will be an integral member of the Biometrics team (including biostatistics, statistical programming, and data management) whose work enables the company to meet defined goals for the clinical development programs. The successful candidate will report to the Head of Biometrics.

 Role and Responsibilities:

  • Serve as a lead biostatistician on clinical projects to develop and execute statistical strategy, design, and analyses for clinical studies
  • Interact with members of the multidisciplinary project teams
  • Oversee CROs biostatistics function and manage project timelines and budget, and review/validate vendors’ deliverables including CDISC data specifications and CSR outputs
  • Participate in NDA submissions and lead the ISE/ISS analyses
  • Collaborate with internal programmers to support publications, DSUR/IB updates, and perform ad-hoc analysis and data validation as needed
  • Provide statistical expert advice and utilize advanced analytical skills to perform simulations

Qualifications:

  • Excellent interpersonal and communication skills
  • Ability to use SAS to perform efficacy and safety analyses
  • Solid knowledge of FDA/EMA guidance
  • Knowledgeable in CDISC standard

Job Requirements and Education:

  • Advanced degree in Statistics/Biostatistics (PhD preferred)
  • 8 years or more of direct hands-on pharmaceutical experience
  • Experience of NDA/BLA is a must
  • Experience of oncology is highly desired

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate