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Director Statistical Programming Jobs in Eatontown, NJ

micro1 AI

Director of Biostatistics

New York, NY · Remote

$60 - $65/hr

Remote micro1 is engaging Biostatisticians to contribute their clinical statistics expertise to a dynamic customer project focused on AI-assisted clinical research. In this role, you'll apply your ...

micro1 AI

Director of Biostatistics

Elizabeth, NJ · Remote

$60 - $65/hr

Remote micro1 is engaging Biostatisticians to contribute their clinical statistics expertise to a dynamic customer project focused on AI-assisted clinical research. In this role, you'll apply your ...

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All JobsStatistical Programming JobsDirector Statistical Programming JobsDirector Statistical Programming Jobs in Eatontown, NJ

Director Statistical Programming information

See Eatontown, NJ salary details

$154.7K

$282.3K

$346.6K

How much do director statistical programming jobs pay per year?

As of Aug 17, 2026, the average yearly pay for director statistical programming in Eatontown, NJ is $282,267.00, according to ZipRecruiter salary data. Most workers in this role earn between $262,500.00 and $324,900.00 per year, depending on experience, location, and employer.

What is a director statistical programming?

The job of a director of statistical programming oversees the development and implementation of SAS programs to produce statistical analysis datasets. In this career, your responsibilities include managing the team that generates tables and graphs using the SAS programs for applications such as clinical studies. Other duties include participating in the planning and review of statistical analysis and studying reports, abstracts, and manuscripts as required. You collaborate with project leads to contribute to department operations and standards, such as CDISC for clinical research.

What does a director statistical programming do?

A Director of Statistical Programming oversees teams responsible for the programming and analysis of clinical trial data, ensuring the accuracy and integrity of statistical outputs. They set departmental strategies, manage resources, and ensure compliance with regulatory requirements and industry standards. This role also involves collaborating with other departments, such as biostatistics and clinical operations, to support the successful delivery of statistical analyses for drug development and regulatory submissions. They play a key leadership role in mentoring staff and advancing programming processes and technologies.

What are the key skills and qualifications needed to thrive as a director statistical programming?

To thrive as a Director of Statistical Programming, you need advanced expertise in statistical analysis, programming languages such as SAS or R, and a strong background in clinical trial data, typically supported by a degree in statistics, mathematics, or a related field. Familiarity with regulatory submission processes, CDISC standards, and project management tools is essential, as are relevant certifications like SAS Certified Professional. Leadership, effective communication, and strategic thinking are key soft skills for managing teams and collaborating across departments. These skills ensure high-quality data outputs, regulatory compliance, and successful execution of complex clinical development projects.

How does a director statistical programming typically collaborate with cross-functional teams in a pharmaceutical or biotech company?

A Director of Statistical Programming regularly works with biostatistics, clinical data management, regulatory affairs, and medical writing teams to ensure that statistical deliverables meet project timelines and regulatory requirements. They coordinate programming efforts across multiple studies, provide leadership and mentorship to programming staff, and help resolve technical or resource-related challenges. Effective collaboration is essential to streamline workflows, maintain data integrity, and ensure clear communication of statistical results within the organization.
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What cities near Eatontown, NJ are hiring for Director Statistical Programming jobs?

Cities near Eatontown, NJ with the most Director Statistical Programming job openings:

Director Statistical Programming jobs near you
Infographic showing various Director Statistical Programming job openings in Eatontown, NJ as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, 2% Temporary, and 1% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $282,267 per year, or $135.7 per hour.

Director, Statistical Programming (Pharma/Biotech Experience Required)

LB Pharmaceuticals, Inc.

New York, NY • On-site

$233K - $244K/yr

Full-time

Posted 12 days ago

Job description

The Director of Statistical Programming is a pivotal, newly created role at LB Pharmaceuticals, reflecting our commitment to building a best-in-class internal Biometrics capability. This individual will serve as the founding leader of our Statistical Programming function, responsible for building the team, infrastructure, and processes from the ground up. The Director will be a hands-on technical leader and strategic partner, working closely with the VP of Biometrics, Biostatistics, Clinical Operations, and Regulatory Affairs to support late-stage clinical trials and BLA submission planning.
Responsibilities
Team & Infrastructure Building
  • Establish and lead the internal Statistical Programming function, defining organizational structure, hiring plans, and resourcing strategy as the company scales toward BLA.
  • Design and implement the programming infrastructure, including SAS/R environments, standard macros, validation frameworks, SDTM/ADaM libraries, and TLF shells aligned with CDISC standards.
  • Develop and maintain SOPs, work instructions, and best practices for all statistical programming activities.
  • Recruit, mentor, and grow a high-performing team of statistical programmers (contractors and FTEs) over time.

Hands-On Programming & Deliverables
  • Serve as lead programmer on CNS clinical trials (schizophrenia, bipolar depression, MDD), including Phase 2 and Phase 3 studies.
  • Develop and validate SDTM and ADaM datasets, TLFs, and supporting documentation for regulatory submissions in full compliance with FDA and ICH guidelines.
  • Lead statistical programming activities for IND/NDA/BLA submissions, including Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), eCTD packaging, Define.xml, Reviewer's Guide, and CDISC compliance checks.
  • Collaborate with Biostatistics to implement statistical analysis plans (SAPs) and provide programming support for ad hoc analyses.

Vendor Oversight & Governance
  • Oversee and manage CRO/vendor statistical programming activities, including scope of work definition, timeline management, quality review, and deliverable acceptance.
  • Establish vendor governance frameworks including quality oversight plans, technical review checklists, and escalation pathways.
  • Ensure vendor-produced datasets, TLFs, and submission packages meet internal and regulatory standards prior to acceptance.

Regulatory & Cross-Functional Collaboration
  • Partner with Regulatory Affairs and Biostatistics to develop and execute the BLA submission strategy and data package planning for LB-102.
  • Liaise with FDA on data standards, submission requirements, and any technical queries related to statistical programming deliverables.
  • Collaborate with Clinical Data Management to ensure alignment on data flow, edit checks, database lock timelines, and data quality.
  • Contribute to Health Authority meetings and respond to regulatory requests related to statistical programming.

Qualifications
  • Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, or a related quantitative field.
  • Minimum 10 years of statistical programming experience in the pharmaceutical or biotech industry, with at least 3 years in a leadership or senior role.
  • Demonstrated experience supporting NDA or BLA submissions, including hands-on SDTM/ADaM development and regulatory-grade TLF production.
  • Deep expertise in SAS (Base, Macro, STAT, ODS); proficiency in R is highly desirable.
  • Strong working knowledge of CDISC standards (SDTM, ADaM, SEND, Define.xml) and FDA/ICH submission guidelines (including 21 CFR Part 11).
  • Proven ability to manage and oversee CRO/vendor programming deliverables in a sponsor oversight capacity.
  • Experience in a small or mid-size biotech environment, including comfort with ambiguity and ability to build processes from scratch.
  • Experience in CNS therapeutic areas, particularly schizophrenia, bipolar disorder, or MDD preferred.
  • Familiarity with FDA expectations for CNS endpoint programming (e.g., PANSS, MADRS, YMRS, CGI scales) preferred.
  • Prior experience building or standing up a statistical programming function at a growing biotech preferred. .
  • PharmaSUG, CDISC, or equivalent industry certifications preferred.

The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $233,175-$244,130.
The Values We Hope You Share
Purpose Driven- We are optimistic, focused and committed to delivering on our vision. We are hard-working, compliant, relentless and impatient in our pursuit of treatments. We set competitive company goals to significantly and positively impact the lives of our patients, employees and shareholders. We have a sense of urgency to every action we make.
Transparent - We trust each other and expect honest and open communication to enable good decision making. We are humble, genuine and direct. Words match our behaviors. We hold each other accountable. We embrace the tough conversations to achieve success.
Bold - We are courageous in our pursuit of excellence. Unafraid of risks. Unafraid of challenging assumptions. Unafraid of challenges. Unafraid of success.
Intelligent - We are curious, passionate and self-aware. We are agile, adaptable and seek diverse experience, knowledge, and skills to make informed, data driven decisions. We anticipate the needs of others, and we adapt quickly to challenges and find solutions. We rely on our collective experiences to diligently develop, strategically plan and efficiently execute our vision.
Unified - We collaborate as we strive for excellence. We rely on each other, and we have each other's backs. We encourage constructive feedback to continually improve. We support each other; we laugh together. We celebrate each other's successes and band together in times of hardship. We foster and appreciate genuine relationships.
Our values underpin the employee experience at LB Pharmaceuticals. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.

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