Director, Statistical Programming

Larimar Therapeutics•Philadelphia, PA

just now

About The Position

The Opportunity: As the Director, Statistical Programming you will lead the Statistical Programming function for our clinical development programs at Larimar, contributing to the vision, direction, and strategy of the statistical programming function and of Statistical and Quantitative Sciences (SQS) as a whole. You’ll build strong collaboration with clinical development and study teams to identify and meet their needs for statistical programming support.

Requirements

Bachelor’s degree or higher in Mathematics, Statistics, Computer Science, or a related field.
10+ years statistical programming experience in biotech/pharmaceutical industry
Experience in managing the Statistical Programming team
Extensive experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
Expert level SAS programmer with experience in delivering complex programming assignments, macros and analyses
Experience in management of CROs with respect to statistical programming

Nice To Haves

Experience with Neurology trials is preferred
Experience with R is a plus
Experience with inspection, BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus

Responsibilities

Collaborate with the IT team to build and maintain secure statistical computing environment and programming infrastructure.
Hands-on statistical programming for CSR, publications, presentations, DSUR, IB, safety data review, and ad hoc analyses
Lead the statistical programming activities for regulatory submissions following CDISC standards
Responsible for the inspection readiness and inspection queries for the statistical programming department
Responsible for the department infrastructure, i.e. consistent directory structure, documentation of deliverables and tracking tools
Collaborate with the study statistician and study team in project planning
Review key study-related documents including but not limited to SAP, CRFs and data management plan
Author SDTM and ADAM specifications in collaboration with the study statistician
Effectively manage the CRO to ensure high-quality deliverables within timeline and budget
Validate/QC key TFLs generated by the CRO
Responsible for one or more studies with concurrent tasks and timelines
Creates departmental SOPs and other processes to conform with industry and regulatory requirements.
Creates data collection and reporting standards within and across programs that conform with industry and regulatory requirements (e.g., CDASH, STDM, ADaM).
Understands regulatory requirements concerning industry technical standards (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) and implications for the department.
Collaborates cross-functionally to resolve departmental issues and ensure effective communication throughout the drug development process.
Develops and maintains programming infrastructure to support SQS activities.
Responsible for recruiting, mentoring, and developing Statistical Programming staff members.
Provides leadership/expertise for day-to-day statistical programming tasks in support of ongoing projects.
Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization