Manager, Statistical Programming

Supernus Pharmaceuticals; Rockville (MD); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Stock awards

Employee stock purchase plan

Discretionary bonus

Job summary

Supernus Pharmaceuticals is a leading biopharmaceutical company focused on CNS disorders. The Manager of Statistical Programming will lead statistical programming for clinical trials, ensuring timely, high‑quality deliverables and adherence to standards.

The role involves overseeing in‑house studies, reviewing SAPs, developing SDTMs/ADaM mappings, and mentoring junior programmers. Strong SAS/R skills and CDISC knowledge are essential.

Qualifications

• Bachelor’s degree in Life Sciences, computer science, mathematics, statistics, or a related field with 5+ years in pharma/clinical research; or a Master’s with 3+ years; or a Ph.D. with 1+ year.
• Proficiency in R is a plus and experience with SAS programming/macros for SDTM/ADaM and TFLs.
• Hands-on knowledge of CDISC standards and generating define packages; familiarity with ICH/FDA guidance.
• Excellent written and oral communication skills; strong attention to detail.

Responsibilities

• Oversee all statistical programming activities for in‑house clinical studies.
• Review SAPs to ensure alignment with study objectives.
• Develop SDTMs and ADaM mappings per SDTM IG.
• Program and validate SDTM/ADaM datasets using SAS.
• Prepare SDTM/ADaM submission packages and define.xml.
• Generate and validate tables, figures, and listings (TFLs).
• Validate outsourced datasets and perform ad hoc analyses as needed.
• Mentor junior programmers and contribute to standards development.

Skills

SAS programming

R (statistical software)

Communication skills

Education

Bachelor's degree in Life Sciences/CS/Math/Statistics

Master's degree

Ph.D.

Tools

SAS

CDISC SDTM/ADaM

Job description

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases including neurological and psychiatric conditions. The company currently markets eight products that have a meaningful impact on patient outcomes.

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

• Oversee all statistical programming activities for in‑house clinical studies, ensuring compliance with Supernus standards.
• Review and provide input on Statistical Analysis Plans (SAPs) to ensure alignment with study objectives.
• Develop Study Data Tabulation Models (SDTMs) and ADaM mapping specifications in accordance with CDISC SDTM Implementation Guides (SDTM IG).
• Program and validate SDTM and ADaM datasets using SAS.
• Prepare SDTM and ADaM submission packages, including define.xml, review guides, and annotated eCRF.
• Generate and validate tables, figures, and listings (TFLs) according to approved specifications.
• Validate outsourced datasets provided by vendors and perform ad hoc analyses as needed.
• Contribute to the development and enhancement of programming standards and workflows.
• Mentor and guide junior programmers to foster skill development and ensure quality deliverables.
• Perform any additional duties as assigned.

Supervisory Responsibilities

• Provide leadership and management consistent with Company values and corporate objectives.
• Understand and guide direct reports according to company policy and procedures.

Knowledge & Other Qualifications

• Bachelor’s degree in Life Sciences, computer science, mathematics, statistics, or a related field and a minimum of five years of experience in a pharmaceutical or clinical research organization, OR a master’s degree and a minimum of three years of experience, OR a Ph.D. and one year of experience.
• Proficiency in R is a plus.
• Demonstrated ability to develop SAS programs and macros for SDTM, ADaM, and TFLs.
• Ability to identify and solve moderately complex problems.
• Working knowledge of CDISC standards and hands‑on experience generating define packages.
• Familiarity with ICH guidelines and FDA guidance related to clinical study conduct and data submission.
• Familiarity with statistical methods applicable to Phase I‑IV clinical trials.
• Excellent written and oral communication skills and strong grammatical/technical writing ability.
• Excellent attention to detail and accuracy.

Other Characteristics

• Ability to work independently and as part of a team while maintaining high ethical standards.
• Innovative and dynamic approach to work.
• Self‑starter who is comfortable working in a team environment.
• Consistently exhibit Supernus values in interactions with employees, vendors, and customers.
• Capable of performing additional duties as assigned by management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements / Work Environment / Travel Requirements

• Sedentary work. May occasionally need to exert up to 10 pounds of force or carry objects.
• Requires close visual acuity for data analysis, screen use, and extensive reading.
• No substantial exposure to adverse environmental conditions.

Compensation

The expected salary range for fully qualified candidates is $100,000 to $130,000.

Competitive benefits include health, dental, vision, paid time off, 401(k) company match, life insurance, wellness benefits, stock equity awards, an employee stock purchase program, and participation in a discretionary annual bonus program.

Equal Opportunity

Supernus Pharmaceuticals is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age, or any other characteristic protected by law.