Senior Statistical Programmer: Lead SDTM/ADaM Submissions

MMS Holdings Inc; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

MMS Holdings Inc is seeking experienced candidates for a Statistical Programming role. The position requires expertise in generating trial data, proficiency in SAS, and a strong understanding of E-Submission Standards.

Candidates should have a Master’s degree in Statistics and at least 5 years of relevant experience. Good organizational skills and a collaborative mindset are crucial for success in this role.

Qualifications

• Minimum of 5 years’ experience in Statistical Programming.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Good communication and problem-solving skills.

Responsibilities

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Utilize System Development Life Cycle (SDLC) for programming deliverables.
• Lead study or small programming project teams.

Skills

SAS programming

System Development Life Cycle (SDLC)

E-Submission Standards knowledge

SDTM standards

ADaM standards

MS Office applications

ICH guidelines

BIMO outputs experience

Education

Masters in Statistics

Job description

MMS Holdings Inc is seeking experienced candidates for a Statistical Programming role. The position requires expertise in generating trial data, proficiency in SAS, and a strong understanding of E-Submission Standards.

Candidates should have a Master’s degree in Statistics and at least 5 years of relevant experience. Good organizational skills and a collaborative mindset are crucial for success in this role.