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REGENXBIO · 1 month ago

Statistical Programming Manager

Rockville, Maryland

Full-time

Hybrid

Mid Level

$122K/yr - $160K/yr

3+ years exp

REGENXBIO is an exceptional place to work, offering collaboration with top professionals in the field. As the Statistical Programming Manager, you will support statistical programming efforts for clinical trials, oversee SAS programming, and ensure quality assurance of outsourced work.

BiopharmaBiotechnologyGeneticsTherapeutics

Responsibilities

Contributes to day-to-day statistical programming activities in support of ongoing projects

Develops SAS outputs as necessary to support data management and clinical review of data

Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirements, and statistical instructions

Develops and/or validates SAS programs to generate statistical output (e.g. TLFs) of clinical trial data as specified in the Statistical Analysis Plan (SAP), as required for regulatory and safety review reasons (i.e. DSUR or IDMC deliverables), and for ad hoc analysis as requested

Documents data and programming information in accordance with SOPs, guidelines and industry standards

Collaborates with team members to help track timelines for statistical programming activities

Assists in the development and maintenance of derived dataset specifications, programming specifications, and other supporting documents

Develops SAS macros, templates and utilities for reporting and data cleaning

Provides oversight to Contract Research Organizations (CROs)

Develops and tests SAS codes for clinical trial database logic checks

Works closely with senior programmers and statisticians to learn best practices and contribute to team deliverables

Qualification

SAS programmingStatistical programmingRegulatory requirementsClinical trial experienceDrug development processCommunication skillsRelationship buildingTime management

Required

Minimum of Bachelor's Degree; Bachelor's Degree in Computer Science, Statistics, Mathematics, or a scientific discipline preferred

SAS programming at an intermediate level

Minimum 3 years of experience in statistical programming in a clinical trial environment

Understanding of the drug development process and the functions and roles in a Pharmaceutical/Biotech clinical organization

Strong knowledge of regulatory requirements as related to statistical programming (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.)

Foundational knowledge of concepts related to statistical programming (e.g., coding dictionaries, annual reporting, EDC systems, etc.)

Outstanding verbal and written communication skills

Ability to effectively manage timelines and priorities

Ability to build successful relationships and interact at the study team level