Ready To Make an Impact

For a CRO providing biometric services (Tigermed-BDM, Inc. d/b/a BDM Consulting, 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.

Hours:  40 per week – Monday through Friday.

Please send your resume to: TGUS-Info@tigermedbdm.com