Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
View more jobs in Morris Plains, NJ
View more jobs in New Jersey

Job Details

Senior Biostatistician

Company name
Immunomedics, Inc.

Morris Plains, NJ

Apply for this job

2 hit(s)  


Job Locations US-NJ-Morris Plains

Posted Date 4 months ago(1/18/2018 11:06 AM)

Job ID 2018-1049

# of Openings 1

Category Clinical


We are seeking a Senior Biostatistician to provide statistical expertise and technical support as it relates to the design and statistical analysis of clinical oncology and autoimmune disease studies. Develop and perform analysis and interpretation of study results.


* Provide timely and scientifically sound statistical guidance and technical expertise to clinical development projects.

* Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.

* Work closely with data management and clinical research/clinical operations personnel to develop and validate study-specific data capture activities.

* Develop statistical analysis plans to meet regulatory standards, coordinate and perform data analysis and validation, and provide data interpretation.

* Produce tables, figures, and listings for reporting of study results and data.

* Assist in the development of study protocols, provide sample size estimates and calculations for study designs, and oversee generation of randomization schedule for complex randomization schemes.

* Review study protocols, CRFs, data validation specifications, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.

* Write specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; perform validation of key statistical results.

* Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output.

* Perform statistical analysis for publication.

* Provide input in preparation of study reports, with particular emphasis on the statistical methods section, and work closely on study report preparation.

* Collaborate with other key personnel in regard to the publication of study data.

* Interact with FDA statisticians and other external parties as required.

* Guide and collaborate with CRO staff to ensure alignment with established data, analysis, and quality standards.

* Stay current with new developments in statistics, drug development, and regulatory guidance.

* May supervise or lead other statistical or programming personnel as assigned.


* PhD degree in biostatistics, statistics, mathematics, or related discipline with 5 years work experience in statistical analysis of clinical trials data OR a MS degree in biostatistics, statistics, mathematics, or related discipline with 7 years work experience in statistical analysis of clinical trials data.

* Proficiency in SAS statistical programming. Must possess strong working knowledge of Microsoft SQL programming and SAS software system including, SAS/BASE, SAS/STAT, SAS/SQL, SAS/ODBC, SAS/ACCESS and SAS/GRAPH. Knowledge of other statistical and data management software/packages a plus.

* Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics; oncology and autoimmune disease experience is highly preferred.

* Experience supporting publication of analysis results (e.g., abstracts, posters, manuscripts).

* Extensive knowledge of industry standards, such as GCP and ICH guidelines, CDISC standards and models, 21 CFR Part 11, and FDA guidelines.

* Familiarity with pharmacokinetic (PK) / pharmacodynamics (PD) data a plus.

* Experience interacting (directly or indirectly) with the FDA.

* Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.

* Effective interpersonal skills and problem solving capabilities. Strong project management and mentoring/leadership skills.

* Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.


Job Type


Job Reference


Job ID


Enter your details to join Resume-Library and apply for this role


First Name

Last Name

This email already exists

Enter your password to login and apply

Forgotten your password?

Apply Now

Company info

Immunomedics, Inc.
Website :

Company Profile

Similar Jobs:
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human hea...
A recruiting firm has a current position open for a Virtual Senior Statistical Programmer.\nMust be able to: Perform data manipulation techniques and advanced techniques Analyze information and develop innovative solutions to prog...
Clinical Research Associate III
Location : Raritan, NJ
Joule, a System One division is seeking a Clinical Research Associate III for a contract position. With more than 6,000 employees and roughly 40 offices throughout the , clinical, engineering, energy, IT, legal and administrative ...
By using Employment Crossing, I was able to find a job that I was qualified for and a place that I wanted to work at.
Madison Currin - Greenville, NC
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ResearchingCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ResearchingCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ResearchingCrossing - All rights reserved. 21