Associate Director, Statistical Programmer

Provides stat programming expertise and strategic leadership to statistical programming function. Responsible for strategic and forward-thinking ideas, processes, standards and systems as well as planning and managing resources to meet business goals. Guidance/thought leader.
Primary Responsibilities Include:

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
• Familiar with statistical analysis methods and clinical data management concepts
• Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets
• Develops and executes statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
• Co-ordinates Statistical Programming activities of assigned project(s) internally and externally (FSP, CRO), assesses resources, negotiates their priority assignments on the project(s) and acts as project manager for statistical programming deliverables
• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, fit-for-purpose analysis datasets, and TFLs
• Provides input in the design and development of case report forms and clinical study databases
• Reviews or authors aCRF, SDTM and ADaM datasets specifications for datasets programming
• Creates and reviews eCTD documents to support regulatory submission package.
• Provides programming support for building integrated summary of safety/efficacy datasets and analysis
• Provides programming support for adhoc analysis
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
• Manages project timelines and schedules of specific phases of projects with internal personnel and external vendors
• Provides oversight of statistical programming activities of vendors
• Participates in the development and review of Statistical Programming SOPs
• Manages programming staff for their projects
• Trains or mentors junior statistical programming staff

Desired Education and Skills:

• MS in Statistics, Computer Science, or a related field with at least 8 years or BS in Statistics, Computer Science, or a related field with at least 10 years.
• Prior experience of independently leading projects for regulatory submission for statistical programming activities.
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA).
• Proficient in SAS programming.
• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
• Experience in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format.
• Experience with FDA and ICH regulations and guidelines.
• Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
• Ability to work independently and act with initiative to address issues at compound level
• Ability to collaborate effectively with colleagues from other functions
• Demonstrate excellent leadership skills.
• Excellent written and verbal communication skills and organizational and documentation skills.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
• Demonstrate positive attitude and the ability to work well with others.

#LI-Remote
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $164,000 - $205,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.