The Associate Director of Statistical Programming is a member of the Biostatistics & Statistical Programming Department and will contribute to Alkermes' continued growth in neuroscience. This role combines technical and project management skills to lead programmers in developing and validating SAS programs for CDISC compliant deliverables that meet regulatory requirements, while also supporting automation and innovation within the programming group to drive efficiency.
Responsibilities
- 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 regulatory submission.
- Produce and validate regulatory submission tables, figures and listings, and support ad-hoc exploratory analysis in a timely and high-quality manner.
- Design, develop, implement and maintain innovative statistical programming automation reporting tools to support multiple projects.
- Provide project management and technical guidance to ensure operational and technical excellence; mentor junior level staff in programming practices, standards implementation and project management.
- Represent statistical programming in cross-functional teams; collaborate closely with 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 the programming environment to ensure data security, efficient analysis and reporting.
Qualifications
Basic Requirements
- Advanced degree strongly preferred (M.S. or Ph.D.) with strong analytical skills.
- Minimum 8+ years of experience 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.
- Extensive experience with CDISC SDTM and ADaM, writing ADaM specifications, and hands-on SAS programming for clinical trial reporting; experience with electronic FDA submission.
- Proficiency in other data analysis programming languages such as R and Python, with ability to learn new languages quickly and motivation to utilize them in clinical development.
- Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials.
- Strong interpersonal, organizational, and multi-tasking skills.
- Excellent attention to detail and problem-solving skills.
- Good project management skills, CRO oversight experience, professional attitude, self-improvement mindset and positive attitude.
- Good written and oral presentation skills and ability to communicate effectively.
- Ability to think creatively and independently, form sound opinions and make sensible decisions in a dynamic environment.
- Neuroscience experience is a plus.
- SAS LSAF experience is a plus.
The annual base salary for this position ranges from $184,071 to $198,796. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.
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.
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