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Invivyd · 3 months ago

Associate Director, Statistical Programming

New Haven, CT

Full-time

Onsite

Lead/Staff, Director/Executive

8+ years exp

Invivyd is a company focused on delivering protection from serious viral infectious diseases, particularly COVID-19. The Associate Director of Statistical Programming will lead statistical programming efforts and manage regulatory submissions, ensuring compliance with standards and collaboration with other functions.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Lead statistical programming and regulatory submission activities

Manage CROs to meet timelines and expectation of quality

Collaborate with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines

Create and validate SDTM, ADaM, and TLFs

Create, validate, and document complex and reusable macros for data cleaning, validation, analysis, customized report and graph generation, and integration of data

Write and review the data specification of SDTM and ADaM data sets

Track clinical trial milestones and work with vendors for statistical reporting deliverables

Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation

Understands and performs in accordance with regulatory standards and drug development principles

Responsible for the creation and accuracy of regulatory submission data and clinical summary report package

Qualification

SAS programmingRegulatory submission experienceCDISC complianceStatistical programmingClinical trial processesData validationLeadershipCollaboration

Required

BS in statistics, biostatistics, engineering, computer science or equivalent area with 8+ years of experience in statistical programming within the pharmaceutical industry

Excellent SAS software programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development (SAS certification is required)

Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)

Extensive experience in defining and implementing CDISC compliant SDTM and ADaM data and specifications

Must be able to travel to New Haven, CT office at least 1x a month