Biostatistician

Experience Required

4 Years

Minimum Education Required

Master of Science Degree

License(s) Required

N/A

Training Required/Provided

N/A

Compensation

$96,900.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Shift

First Shift (Day)

Job Description

For a CRO providing biometric services (Tigermed-BDM, Inc. - Somerset, NJ): serve as a lead Biostatistician on global Phase I–IV clinical trials in oncology, autoimmune and vaccine therapeutic areas, providing input on study design and authoring statistical sections of protocols and Statistical Analysis Plans (SAPs); lead cross-functional and programming teams to design, program and validate CDISC-compliant SDTM and ADaM datasets and specifications for multi-regional clinical trials (MRCTs), and develop and quality-check standard Tables, Figures and Listings (TFLs), including mock shells and reusable SAS macros for analysis and reporting; prepare, validate and document submission-ready electronic packages for health authorities (e.g., FDA), including analysis datasets, TFLs, Define-XML, SDTM Reviewer’s Guide (SDRG) and ADaM Reviewer’s Guide (ADRG); perform regulatory compliance checks using tools such as Pinnacle 21, resolve findings and support ad-hoc analyses for regulatory queries, independent data monitoring committees (IDMC/DSMC), development safety update reports (DSURs) and scientific publications.

Requirements:

1. Master of Science or foreign equivalent degree in Biostatistics, Statistics or a related field.

2. 4 years of experience in the job offered or 4 years of SAS statistical programming experience. The required experience must include SAS macros for clinical trial data analysis and reporting, creating and validating CDISC-compliant SDTM and ADaM datasets and specifications, generating and validating TFLs for clinical study reports and regulatory submissions, authoring and/or reviewing SAPs and related statistical documentation, supporting FDA electronic submissions, including Define-XML and SDTM/ADaM reviewer’s guides (SDRG/ADRG), and using Pinnacle 21 or similar tools for regulatory compliance checks and responding to issues. Experience can be gained while pursuing degree.

3. National Telecommuting.

Place of Work

Remote

Requisition ID

JO05192026

Job Type

Full Time

Application Email

View email address on click.appcast.io