Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Associate Director, Statistical Programming

Novartis
Novartis
3-10 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Statistical Programming

Location: London (The Westworks)

Job Type: Full-time

Application Deadline: March 28, 2025


Job Summary:

Novartis is seeking an Associate Director, Statistical Programming to lead statistical programming activities for early drug development programs within Immunology, Cardiovascular & Metabolic Diseases, or Neuroscience. This role involves strategic decision-making, cross-functional collaboration, and regulatory compliance to ensure high-quality and timely data delivery.

The ideal candidate will have strong leadership experience, expertise in SAS/R programming, a solid understanding of clinical trials methodology, and a background in early development, preferably in oncology.


Key Responsibilities:

Strategic & Operational Leadership:

  • Lead statistical programming (SP) activities for multiple clinical trials within a program or indication/disease area.
  • Make strategic statistical programming decisions at the program or indication level.
  • Develop scientific documentation in collaboration with Biostatisticians.
  • Represent Statistical Programming (Early Development) in audits, inspections, Health Authority (HA) meetings, and industry conferences (e.g., CDISC).

Resource & Team Management:

  • Allocate and manage resources within and across programs.
  • Supervise, mentor, and develop internal and external statistical programmers (managing teams of 6-15 programmers).
  • Conduct performance appraisals and provide career development support.

Cross-functional Collaboration & Communication:

  • Build and maintain effective relationships with clinical trial and program team members.
  • Summarize and communicate programming deliverables, timelines, and resource plans across functions.
  • Ensure regulatory compliance and readiness for Health Authority inspections.

Technical Expertise & Compliance:

  • Maintain advanced knowledge of SAS/R programming and statistical reporting techniques.
  • Ensure adherence to CDISC, eCTD, Define.xml, and regulatory standards.
  • Drive innovation and efficiency in statistical programming practices.

Qualifications & Experience:

Education & Industry Experience:

  • BS/MS degree in Life Sciences, Computer Science, Statistics, Mathematics, or a related field.
  • 10+ years of industry experience, with 6+ years in statistical programming.
  • 2+ years as a Lead/Program/Project Programmer for one or more programs/indications.
  • 3+ years of line or matrix management experience (for people managers).

Technical & Business Skills:

  • Expertise in SAS or R programming (including development and validation of deliverables).
  • Experience in developing advanced MACROs and statistical programming functions.
  • Strong knowledge of CDISC standards, regulatory submissions, and industry best practices.
  • Deep understanding of clinical trial methodology, regulatory requirements, and GCP.
  • Ability to manage multiple trials simultaneously while meeting tight deadlines.

Preferred Experience:

  • Prior early development experience, ideally in Oncology.
  • Strong interpersonal and leadership skills to operate in a global environment.

Skills & Competencies:

  • Statistical Analysis & Data Structures
  • Clinical Trial Data Programming
  • Cross-functional Team Collaboration
  • People Management & Leadership
  • Regulatory Compliance (CDISC, GCP, eCTD, Define.xml)
  • Project & Risk Management
  • Programming Languages (SAS/R)
  • Data Analysis & Reporting

Languages Required:

  • English (Fluent)

Why Join Novartis?

  • Innovative Science: Work at the forefront of drug development and statistical programming.
  • Career Growth & Development: Opportunities to lead, mentor, and shape statistical programming strategies.
  • Global Impact: Contribute to life-changing treatments in Immunology, Cardiovascular & Metabolic Diseases, and Neuroscience.
  • Collaborative & Inclusive Culture: Work in a diverse, global team that supports and inspires innovation.

🚀 Join Novartis and be a part of groundbreaking medical advancements!


Commitment to Diversity & Inclusion:

Novartis is committed to fostering an inclusive and diverse workplace that reflects the communities we serve. We encourage applications from all backgrounds.


Join Our Talent Network:

If this role isn't the right fit, stay informed about future career opportunities by signing up for our Novartis Talent Network here: Novartis Careers

📢 Please note that visa sponsorship is currently unavailable for this position.

#Novartis #StatisticalProgramming #ClinicalTrials #SAS #RProgramming #CDISC #Biostatistics #PharmaceuticalCareers