Lead Biostatistician - NDA Submissions & SAPs

Datawise Inc; New Jersey; Remote; USD 90,000 - 120,000; Full time

Job summary

Datawise Inc. in New Jersey is seeking a Senior Biostatistician to lead statistical activities for clinical trials, including randomization, SAP development, and reporting. You will review CRFs and data management docs, and mentor junior biostatisticians while collaborating with clients.

The role emphasizes NDA submissions, end-to-end statistical workflows, and strong SAS/R expertise within a fast-paced environment. A doctorates not required but extensive experience is valued.

Qualifications

• Master’s degree or higher in Biostatistics, Statistics, Mathematics, or related field; NDA submissions valued.
• Minimum five years of hands-on experience in clinical trial biostatistics.
• Strong proficiency in SAS and R, including Base SAS, Macros, SAS/GRAPH, SAS/STAT.
• Solid knowledge of CDISC standards (CDASH, SDTM, ADaM).
• Experience in developing and reviewing SAPs and outputs with missing data methods (e.g., multiple imputation).

Responsibilities

• Lead statistician for randomization activities, including preparation of randomization documentation and generation of randomization schedules.
• Create SAPs, TLF shells, and statistical reports across studies of varying complexity.
• Review and quality-check CRFs and data management documentation (edit checks, data review plans, data transfer specs).
• Provide guidance and mentorship to statistical programmers on study design and analysis methods.
• Support and mentor junior biostatisticians in statistical tasks and project activities.

Skills

SAS programming

R programming

CDISC standards knowledge

Education

Master's degree in Biostatistics or related field

Bachelor's degree with equivalent experience

Tools

Base SAS

SAS Macros

SAS/GRAPH

SAS/STAT

Job description

Datawise Inc. in New Jersey is seeking a Senior Biostatistician to lead statistical activities for clinical trials, including randomization, SAP development, and reporting. You will review CRFs and data management docs, and mentor junior biostatisticians while collaborating with clients.

The role emphasizes NDA submissions, end-to-end statistical workflows, and strong SAS/R expertise within a fast-paced environment. A doctorates not required but extensive experience is valued.