Manager, Statistical Programming

Job Summary

The Manager of Statistical Programming will lead and support statistical programming activities for clinical projects conducted by Supernus Pharmaceuticals. This role ensures the timely delivery of high-quality clinical trials analysis deliverables by adhering to established standards and processes.

Essential Duties & Responsibilities

• Oversees all statistical programming activities for an in-house clinical study, ensuring compliance with Supernus standards.
• Reviews and provides input on Statistical Analysis Plans (SAPs) to ensure alignment with study objectives.
• Develops Study Data Tabulation Models (SDTMs) and Arrangement of variables (ADaM) mapping specifications in accordance with CDISC SDTM Implementation Guides (SDTM IG).
• Programs and validates SDTM and ADaM datasets using SAS programs.
• Prepares SDTM and ADaM Submission packages, including, define.xml, Reviews guide, and annotated eCRF.
• Generates and validates Tables, Figures, and listings (LTFs) according to approved specifications.
• Validates outsourced datasets provided by vendors and performs ad hoc analyses as needed.
• Contributes to the development and enhancement of programming standards and workflows.
• Mentors and guides junior programmers to foster skill development and ensure quality deliverables.
• Performs other duties as assigned.
• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.

Knowledge & Other Qualifications

• Bachelor’s degree in Life Sciences, computer science, mathematics, statistics, or a related quantitative/analytical field with a minimum of five years of experience in a pharmaceutical/ Clinical Research organization industry, a master’s degree in a related field with a minimum of three years of experience, or a PhD with one year of experience.
• Proficiency in R is a plus.
• Demonstrated ability to develop SAS programs and macros to create SDTM, ADaM, and TFLs.
• Demonstrated ability to identify and solve moderately complex problems.
• Familiarity with ICH guidelines and FDA guidance related to clinical study conduct and data submission.
• Familiarity with statistical methods that apply to Phase I-IV clinical trials.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.

Other Characteristics

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• Able to work independently but comfortable working in a team environment.
• Able to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.

Physical Requirements/Work Environment/Travel Requirements

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects.
• Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Compensation

The expected salary range for fully qualified candidates applying for this role is $100,000 to $130,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.