CTG SENIOR CLINICAL STATISTICIAN in Whippany, New Jersey

Title: SENIOR CLINICAL STATISTICIAN

Location: US-NJ-Whippany

Job Number: 17204515

CTG's premier global client in Whippany, NJ has a 12-month contract assignment for a Senior Clinical Statistician. There is the potential for extension after the initial contract period.

The maximum W2 hourly rate will be $75.00/hr (based on experience).

JOB PURPOSE

Statistics is an integral part of drug discovery, development, regulatory approvals, and post marketing activities. Medical Affairs statisticians are core members of multidisciplinary teams responsible for designing, planning and conducting analyses for post marketing clinical studies as well as observational studies. In addition, our statisticians perform exploratory analyses on existing company clinical databases and also meta-analyses using published data. With our statistical expertise we contribute to a scientifically based decision process utilizing optimized development plans, best in class study designs and state-of-the-art statistical analyses in accordance with regulatory and payer requirements.

A Senior Statistician provides statistical expertise to cross-functional teams and ensures the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management of our pharmaceutical products according to applicable global and regional standards, procedures and regulatory guidelines.

DUTIES AND RESPONSIBILITIES

• Collaborate with representatives from other functions in designing, planning and conducting analyses of post marketing clinical studies and observational studies

• Perform exploratory analyses from existing company clinical databases and perform meta-analyses

• Collaborate with Medical Affairs teams on publications, presentations and posters

• Perform scientific review of study protocols and study proposals

• Develop statistical methodologies for analyzing data from Real Life Evidence projects (observational studies, epidemiology and RLE databases)

• Provide statistical guidance and training to cross functional teams

• Assume responsibility for the production and accuracy of the statistical analysis and interpretation of the statistical analysis results

• Work independently on routine and complex statistical questions and tasks

• Oversee and ensure accurate and timely delivery of statistical work outsourced to external providers

QUALIFICATIONS

• MS/PhD degree in statistics/biostatistics or a relevant field

• At least four years of experience working with/analyzing Phase II/III clinical trial data (in pharmaceutical or CRO), and preferably experience with observational studies

• Good knowledge of clinical trial designs, common analysis methods, descriptive and inferential statistics, summarization of data and presentation practices

• Hands on experience of survival analyses and categorical data analyses

• Knowledge in epidemiology and meta-analyses is a plus

• Proficiency in SAS

• Experience in writing statistical analysis plans, including table shell specifications

• Good knowledge of CDISC SDTM and ADaM

• Ability to work independently, toward the primary responsibility of generating and validating analyses and preparing supporting documentation

• Good oral and written communication skills

PREFERENCES

• Oncology experience preferred

• Proficiency in R and/or EAST is a plus

CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.

Qualifications:

CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.

CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.

Job: Statistics