Senior Manager, Principal Statistical Programmer, Biometrics

Society for Conservation Biology; Cheltenham Township (PA); Hybrid; USD 127,000 - 191,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Principal Statistical Programmer to join their Biometrics team. The role involves developing statistical programming deliverables for clinical trials, ensuring compliance with CDISC standards, and providing project management guidance. Candidates should have extensive experience in the biopharmaceutical industry, advanced SAS skills, and a commitment to diversity and inclusion.

Benefits

Flexible work environment

Premium benefits package

Deliberate professional development

Commitment to diversity and community involvement

Qualifications

• 7+ years in biopharmaceutical industry.
• 3+ years project management experience as a statistical programmer.
• Hands-on SDTM mapping experience.

Responsibilities

• Develop programming specifications for SDTMs and analysis datasets.
• Ensure compliance with regulatory requirements and standards.
• Review statistical analysis plans and case report forms.

Skills

SAS

Project Management

Statistical Programming

Communication

Education

MS or equivalent degree

Tools

CDISC

Rave

Veeva

Medidata

Job description

Senior Manager, Principal Statistical Programmer, Biometrics

Employer: Agios Pharmaceuticals
Location: Elkins Park, Pennsylvania, US
Salary: Competitive
Closing date: May 20, 2025

Sector: Consultancy/Private Sector
Field: Informatics / GIS
Discipline: Project Management
Job Level: Senior level
Salary Type: Salary
Employment Type: Full time

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners, and colleagues, which helps us discover, develop, and deliver therapies for rare diseases — making a significant difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for treating hemolytic anemia in adults with PK deficiency. Building on our leadership in cellular metabolism, we are advancing a robust pipeline of investigational medicines in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency, and MDS-associated anemia.

The impact you will make:

We are seeking a dynamic Principal Statistical Programmer to join our growing Biometrics team. You will be responsible for study-level statistical programming deliverables, including developing programming specifications and programs to generate SDTMs and analysis datasets using Agios or CDISC standards, reviewing CRFs, creating SDTM-annotated CRFs, reviewing statistical analysis plans, analyses datasets, outputs, and performing hands-on statistical programming activities. You will also review deliverables from CROs. Working knowledge of CDISC requirements and Pinnacle 21 is essential.

What you will do:

1. Provide technical and project management guidance in SAS programming for analyzing and reporting clinical trial data and electronic submissions in CDISC format.
2. Develop or validate programming specifications and programs for SDTMs and analysis datasets, adhering to standards and study-specific requirements.
3. Create tables, listings, and figures based on standards or specific requirements.
4. Develop SDTM-annotated CRFs.
5. Ensure timely and high-quality delivery of study-level statistical programming activities.
6. Review statistical analysis plans and case report forms.
7. Maintain documentation compliant with CDISC standards for audits.
8. Establish and maintain statistical programming standards at Agios.
9. Ensure compliance with regulatory requirements, SOPs, and standards.
10. Participate in cross-functional teams on SOPs, guidelines, and system improvements.

What you bring:

• MS or equivalent degree.
• 7+ years in biopharmaceutical industry.
• 3+ years project management experience as a statistical programmer.
• Advanced SAS skills (Base, Macro, STAT, Graph, SQL).
• Experience developing and validating analysis datasets, tables, listings, and figures.
• Hands-on SDTM mapping experience.
• Knowledge of clinical database design, especially electronic data capture (Rave, Veeva, Medidata).
• Experience supporting electronic submissions (eCTD).
• Excellent communication skills.
• Experience with Real World Data is a plus.

We encourage applicants who may not meet every requirement to apply, as we value diverse experiences and perspectives. We are committed to an inclusive, diverse, equitable, and accessible environment.

Work Location:

Location agnostic: remote in the US or hybrid at our Cambridge headquarters. Hybrid schedules are generally less than 3 days onsite. Remote employees work from home, with travel possible for company events.

What we will give you:

• Deliberate professional development.
• Flexible work environment supporting individual needs.
• Premium benefits package.
• Competitive, performance-based compensation.
• Salary range: $127,219 - $190,828, based on experience and qualifications.
• Psychological safety and a culture of open communication.
• Commitment to diversity and community involvement.