Lead Statistical Programming - Clinical Trials

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 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.