Associate Director, Statistical Programming

Alkermes Plc

Waltham, MA

JOB DETAILS
SKILLS
Analysis Skills, Automation, Biostatistics, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Computer Programming, Cross-Functional, Data Sets, Disease, Information/Data Security (InfoSec), Leadership, Medical Products, Mentoring, Multitasking, Neurology, Neuroscience, Operations Management, Outsourcing, Pre-Clinical Development, Project/Program Management, Psychiatry and Mental Health, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Security Analysis, Statistical Analysis System (SAS), Statistical Programming Languages, Technical Leadership, Time Management
LOCATION
Waltham, MA
POSTED
13 days ago
  • 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

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.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

About the Company

A

Alkermes Plc