Contract, Biostatistician

28 Jun 2024

Vacancy expired!

IKCON PHARMA, INC, an affiliate of IKCON TECHNOLOGIES, INC provides innovative services & solutions to our clients who develop novel, modern medicines to improve the lives of patients globally. By utilizing digital technologies, we can transform how sponsors approach clinical development by improving the patient experience, enhancing clinical trial productivity, increasing the quality of data collected in trials, and incorporating valuable insights from multiple sources of data. "U.S. Citizens and those authorized to work in the U.S. are encouraged to apply." JOB TITLE Contract, Biostatistician CITY Remote STATE Remote TAX TERMS W2 EXPERIENCE 7+ Years INTERVIEW MODE Telephonic/Skype JOB DESCRIPTION: MUST HAVE:

  • Must have at least 5-6 years of CRO biostatistics experience
  • Strong SAS programming skills as the contractor needs to validate the programmer's work
  • Neuroscience therapeutic area is strongly preferred.
  • Not interested in candidates that only have oncology experience but will consider candidates with oncology and other therapeutic areas experience.
  • Looking for a do-er. The biostatistician will oversee phase 2 and 3 studies.
ESSENTIAL FUNCTIONS Primary duties/responsibilities:
  • Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta- analyses, publications activities, scientific presentations and promotional material.
  • Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally.
  • Participates in vendor evaluation, selection, and management.
  • Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
  • Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data in a way that supports a high quality database for the planned analyses.
  • Authors and manages the implementation of statistical analysis plans.
  • Authors and reviews statistical and outcome sections of study reports and submissions.
  • Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum level of education and years of relevant work experience.
  • PhD in Statistics or a related statistical discipline and a minimum of 6 years of statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment OR Master's degree in Statistics or related statistical discipline and a minimum of 8 years of statistical experience in a pharmaceutical, biotechnology, CRO or related environment.
Special knowledge or skills needed and/or licenses or certificates required.
  • Hands-on experience supporting clinical studies and working with clinical teams and interacting with regulatory agencies.
  • Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry.
  • Hands-on statistical programming skills using SAS and/or R.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Special knowledge or skills and/or licenses or certificates preferred.
  • Excellent understanding of regulatory requirements and guidance document.
Travel requirements
  • 0-10%

  • ID: #43657123
  • State: New Jersey Southplainfield 07080 Southplainfield USA
  • City: Southplainfield
  • Salary: USD TBD TBD
  • Job type: Contract
  • Showed: 2022-06-28
  • Deadline: 2022-08-26
  • Category: Et cetera