ZipRecruiter

Log In

1

Associate Director Statistical Programming Jobs in Apex, NC

AskBio

Associate Scientist, Immunology

Durham, NC · On-site

Speak with your direct manager to discuss your interest and alignment with your development goals ... Perform in-depth data analysis using advanced statistical and bioinformatics tools, and draw ...

AskBio

Associate Scientist, Immunology

Durham, NC · On-site

Speak with your direct manager to discuss your interest and alignment with your development goals ... Perform in-depth data analysis using advanced statistical and bioinformatics tools, and draw ...

RSM

Solutions Architecture Associate Director

Raleigh, NC · On-site

$61.25 - $80.75/hr

Provide technical mentorship to senior engineers and conduct design and code reviews ... The salary range (or starting rate for interns and associates) for this role represents numerous ...

New

RSM

Solutions Architecture Associate Director

Raleigh, NC · On-site

$61.25 - $80.75/hr

Provide technical mentorship to senior engineers and conduct design and code reviews ... The salary range (or starting rate for interns and associates) for this role represents numerous ...

New

previous page

Showing results 41-60

All JobsAssociate Statistical Programming JobsAssociate Director Statistical Programming JobsAssociate Director Statistical Programming Jobs in Apex, NC

Associate Director Statistical Programming information

See Apex, NC salary details

$117K

$213.5K

$262.1K

How much do associate director statistical programming jobs pay per year?

As of Aug 14, 2026, the average yearly pay for associate director statistical programming in Apex, NC is $213,461.00, according to ZipRecruiter salary data. Most workers in this role earn between $198,500.00 and $245,700.00 per year, depending on experience, location, and employer.

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

To thrive as an Associate Director Statistical Programming, you need expertise in statistical programming, clinical trial data standards, and a degree in statistics, mathematics, or a related field, often with several years of experience in the pharmaceutical or biotechnology industry. Proficiency in programming languages such as SAS and R, knowledge of CDISC standards (SDTM, ADaM), and familiarity with regulatory submission requirements are typically required. Strong leadership, project management, and communication skills are vital for guiding teams and collaborating with cross-functional partners. These skills and qualities ensure the delivery of high-quality, compliant statistical outputs that support clinical development and regulatory approval.

What does an associate director statistical programming do?

An Associate Director of Statistical Programming leads teams responsible for the design, development, and validation of statistical programs used in the analysis of clinical trial data. They oversee the creation of datasets, tables, listings, and figures that support regulatory submissions and scientific publications. In addition to technical expertise, this role involves managing timelines, ensuring compliance with regulatory standards, and collaborating with cross-functional teams such as biostatistics, data management, and clinical operations.

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

As an Associate Director of Statistical Programming, you will work closely with biostatisticians, clinical data managers, and regulatory affairs professionals to ensure that statistical analyses and data outputs meet project and regulatory requirements. You’ll often lead programming teams, coordinate timelines, and help translate statistical analysis plans into executable code. Regular meetings and clear communication are key, as you’ll be expected to provide technical guidance and ensure data integrity across multiple studies or programs. This role often requires balancing hands-on programming with strategic leadership and mentorship responsibilities.

What is the difference between Associate Director Statistical Programming vs Statistical Programmer?

AspectAssociate Director Statistical ProgrammingStatistical Programmer
Required CredentialsBachelor's or Master's in Biostatistics, Statistics, or related field; experience in clinical trial programmingBachelor's or Master's in similar fields; entry to mid-level experience
Work EnvironmentLeads teams, manages projects, collaborates with cross-functional teamsPerforms programming tasks, supports project teams, executes statistical analyses
Employer & Industry UsagePharmaceutical and biotech companies, clinical research organizationsPharmaceutical companies, CROs, biotech firms

The Associate Director Statistical Programming typically oversees programming teams and manages project deliverables, requiring leadership skills and extensive experience. In contrast, the Statistical Programmer focuses on executing programming tasks under supervision. Both roles are essential in clinical research, but the Associate Director holds more managerial responsibilities and strategic oversight.

What are popular job titles related to Associate Director Statistical Programming jobs in Apex, NC?

For Associate Director Statistical Programming jobs in Apex, NC, the most frequently searched job titles are:

What job categories do people searching Associate Director Statistical Programming jobs in Apex, NC look for?

The top searched job categories for Associate Director Statistical Programming jobs in Apex, NC are:

What cities near Apex, NC are hiring for Associate Director Statistical Programming jobs?

Cities near Apex, NC with the most Associate Director Statistical Programming job openings:

Associate Director Statistical Programming jobs near you
Infographic showing various Associate Director Statistical Programming job openings in Apex, NC as of August 2026, with employment types broken down into 100% Full Time. Highlights an 60% In-person, and 40% Hybrid job distribution, with an average salary of $213,461 per year, or $102.6 per hour.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • Remote

Full-time

Posted 28 days ago

Job description

Position Summary:

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.


Key Responsibilities:

CMC Regulatory Strategy

  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.

Regulatory Submissions

  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.

Health Authority Interactions

  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.

Cross-Functional Collaboration

  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.

Regulatory Intelligence & Compliance

  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.


Qualifications:

Education

  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.

Preferred Qualifications

  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.

Associate Director Experience

  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.

Director Experience

  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.

Knowledge & Skills

  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.

Key Competencies

  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines