Senior Manager, Biostatistics
At a glance
Senior Data Science role at Integrated Resources INC. Woodcliff Lake · full-time · no salary stated · we estimate $150,000–$205,000 across the United States.
Integrated Resources INC has not published a salary for this role. The figure below is our estimate, not theirs.
dataroles summary, based on the employer's posting.
What you'll do
- Guide protocol development and study startup, then prepare SAPs, table shells, variable definitions and DMC plans
- Provide statistical and validation input for analysis datasets and statistical tables, and carry out and check analyses
- Review clinical study reports on your own and explain what the data show
- Prepare biostatistics contributions to regulatory documents and answer health authority questions with any requested analyses
- Coordinate CROs supporting Phase II and III neurology studies
What you bring
- Industry experience applying biostatistics methods and processes in clinical development
- A PhD is preferred; relevant education paired with experience may also qualify
- You bring capability in statistical analysis, programming, regulatory processes and biostatistics project management
Who this fits
This senior individual-contributor role suits a statistician able to work with little supervision. You will support Phase II and III neurology studies and work onsite in Woodcliff Lake.
From the employer
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
The Senior Manager, Biostatistics - Neuroscience will be expected to work independently with minimal supervision, serving as study statistician for clinical studies. The study statistician will be accountable for supporting protocol development and study initiation, developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter, providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation, supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The immediate need is to support Phase II and III studies within the Neurology Business Group.
PhD strongly preferred, but combination of education and experience may be considered in lieu of PhD
Experience in clinical development biostatistics methods and processes in industry setting required
Functional Technical Competency in the following:
Clinical Development
Plan Creation
Statistical
Analysis
Statistical Programming
Regulatory Process for Biostatistics
Business Knowledge
Therapeutic Area Knowledge
Regulatory Knowledge
Project and Resource Management
Compliance
we do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724|
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
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