DescriptionPosition Summary: The Senior Director, Statistical Programming leads our data and analytics efforts. In this role, you will build and manage the statistical programming strategies, SAS frameworks, and team standards needed to support Aclaris's clinical programs. You will manage programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests. This role will be hands-on initially with the opportunity to build the function as our clinical programs advance.
Essential Duties and Responsibilities:- Lead the statistical programming team by creating clear workflows, standards, and standard operating procedures (SOPs).
- Manage programming timelines for clinical studies and oversee the work of CROs and external vendors.
- Partner with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high-quality data deliverables in timely fashion.
- Help develop new data review tools and reporting applications alongside the Biostatistics team.
- Review and check SAS programs created by CROs to ensure they meet standard (e.g., SDTM, ADaM) and custom (e.g., non-standard datasets and TFLs) study requirements.
- Develop SAS infrastructure and programming processes to make routine reporting and ad hoc data requests more efficient.
- Review and provide expert feedback on study documents like SAPs, DMPs, CRFs, data and TFL programming specifications.
- Hire, train, and mentor a team of programmers to support our growing clinical trials.
- Run ad hoc data analyses as needed to support business decisions.
Additional Responsibilities: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
RequirementsRequired Education and Experience:- Master's Degree in Statistics, Biostatistics, Mathematics, or a related field.
- At least 10 years of clinical trial programming experience in the pharma or biotech industry.
Required Knowledge, Skills, Abilities & Behaviors: - Strong SAS programming skills, with some experience using other tools like R.
- Deep understanding of CDISC standards, including SDTM, ADaM, and controlled terminologies.
- Great organizational skills and the ability to balance multiple tasks in a fast-paced environment.
- Strong communication skills and the ability to explain technical data concepts to other teams.
- Proven experience managing CROs and external data vendors.
- A supportive leader who values a collaborative and psychologically safe team environment.
- Good working knowledge of FDA, EMA, and ICH regulatory guidelines.
- Comfortable working and leading in a fully remote, virtual environment.
- Willing and able to travel for business as needed.
