Associate Director/Director Statistical Programming

GQR; Boston (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking an Associate Director/Director of Statistical Programming to lead statistical programming activities for clinical trials. In this pivotal role, you'll ensure the quality of programming deliverables and manage ad-hoc analyses for publications and regulatory inquiries. With a focus on innovative therapeutics for rare diseases, this role offers a dynamic environment where your expertise in SAS programming and project management will shine. Collaborate with cross-functional teams and contribute to impactful initiatives in the biopharmaceutical sector.

Qualifications

• 8+ years of statistical programming experience in the CRO or pharmaceutical industry.
• Proven ability to collaborate with cross-functional teams to drive initiatives.

Responsibilities

• Oversee statistical programming activities for multiple clinical trials.
• Perform programming analyses for publications and regulatory requests.

Skills

Statistical Programming

SAS Programming

Project Management

Regulatory Submissions

Data Collection Concepts

Issue Resolution

Communication Skills

Education

BS/MS in Life Sciences

Statistics

Computer Science

Mathematics

Tools

Pinnacle 21

Job description

Associate Director/Director Statistical Programming

This role can either be perm, contract-to-perm or contract.

Position Overview:

• Oversee statistical programming activities for multiple clinical trials and perform quality review of CRO/Vendor SAS programs and deliverables.
• Perform programming analyses to generate ad-hoc requests for publications, presentations, and responses to regulatory agencies' requests.

Reporting Relationship: Reports to the VP, Biometrics.

About the Company:

A clinical-stage biopharmaceutical company focused on developing innovative therapeutics for rare diseases.

Desired Skills & Experience:

• 8+ years of statistical programming experience in the CRO or pharmaceutical industry.
• 7+ years of people and/or project management experience in the CRO or pharmaceutical industry.
• BS/MS degree in life sciences, computer science, statistics, mathematics, or a related field.
• Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
• Familiarity with validation tools, such as Pinnacle 21.
• Strong understanding of data collection and database concepts, including clinical trial data collection processes.
• Experience with outsourcing programming activities and overseeing CROs and contractors.
• Experience in regulatory submissions.
• In-depth knowledge of pharmaceutical clinical development, including statistical concepts, techniques, and clinical trial principles.
• Familiarity with industry standards such as CDISC data standards, controlled terminology, FDA guidance (e.g., 21 CFR Part 11), and ICH requirements.
• Ability to develop and implement strategies for efficiency in a fast-paced environment.
• Skilled in issue resolution, process improvement, and execution.
• Excellent verbal and written communication skills in a global setting.
• Proven ability to collaborate with cross-functional teams, including Data Management, Biostatistics, Clinical Operations, Pharmacovigilance, and Medical Affairs, to drive initiatives and improvements.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Other

Industries

• Biotechnology Research, Pharmaceutical Manufacturing, and Research Services