Associate Director, Statistical Programming

The Associate Director of Statistical Programming, as a member of the Biostatistics & Statistical Programming Department, will contribute to Alkermes to achieve the goals of continuing growth in neuroscience. The Associate Director will combine technical and project management skills to lead programmers to develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in CDISC compliance to meet regulatory requirements. In addition, this individual will support the automation and innovation within programming group to drive effective and efficient statistical programming.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

• Function as lead programmer to coordinate all activities related to study or project level statistical programming activities.

• Design and develop programming specifications and SAS programs for producing and validating CDISC compliant datasets to support the generation of outputs for regulatory submission.

• Produce and validate regulatory submission tables, figures and listings, support ad-hoc exploratory analysis in a timely fashion and of high quality

• Design, develop, implement and maintain innovative statistical programming automation reporting tools to effectively support multiple projects.

• Provide project management and technical guidance to ensure operational and technical excellence. Mentor junior level staff in programming practices, implementation of standards and project management.

• Represent statistical programming in cross-functional teams. Work in close collaboration with other functions including biostatistics, clinical operations, data management and regulatory operations to define deliverables, develop timelines and ensure alignment of expectations

• Work with IT to develop and maintain programming environment to ensure data security and efficient analysis and reporting

Basic Requirements:

• Advanced degree strongly preferred (M.S. or Ph. D) with strong analytical skills

• Minimum 8+ years experiences in pharmaceutical/biotech and/or CRO setting

Preferred Requirements:

• Proven expert in SAS programming and analytical skills using BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS etc.

• Extensive CDISC SDTM and ADaM knowledge with significant experience writing ADaM specifications using robust and detailed instructions. Strong hands-on SAS programing skills for clinical trial reporting. Experience with electronic FDA submission.