Description
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.
Role and Responsibility
- 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.
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 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
- Experience in management of CROs with respect to statistical programming
- Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization