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- Tasks: Lead statistical programming for clinical trials and ensure quality and compliance.
- Company: Join Novartis, a leader in drug development dedicated to improving lives.
- Benefits: Enjoy a collaborative culture, diverse teams, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while working with passionate professionals.
- Qualifications: BS/MS in relevant fields with 10+ years of industry experience required.
- Other info: Opportunity to mentor and lead a team of programmers in a global environment.
The predicted salary is between 43200 - 72000 £ per year.
The Early Development, Associate Director, Statistical Programming, is responsible for all statistical programming aspects of one or more drug development programs or indication programs within the Early Development space. As a program lead, the Associate Director ensures cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug lifecycle management. They ensure that the trials/programs are adequately resourced and oversee all aspects of programming, quality, and regulatory compliance. This key leadership position ensures the efficient execution of trial/program level plans, delivering high-quality results on time. A thorough understanding of the drug development process, experience in regulatory activities, and expertise in statistical reporting, along with a proven track record in operational or functional leadership, are required.
Responsibilities:
- Lead statistical programming activities for multiple clinical trials within a program or indication/disease area.
- Coordinate activities of internal/external programmers.
- Make statistical programming decisions and propose strategies at the program or indication/disease level.
- Develop scientific documentation for the program(s) or indication/disease area with the Biostatistician(s).
- Allocate resources within a program and ensure resource sharing between programs to meet organizational goals.
- Recruit, mentor, and evaluate statistical programmers.
- Conduct performance appraisals of direct reports, as applicable.
- Build and maintain effective working relationships with cross-functional team members, and communicate the status of deliverables and critical programming aspects effectively.
- Maintain up-to-date knowledge of programming software (e.g., SAS/R) and industry standards (e.g., CDISC, eCTD, Define.xml).
- Attend functional meetings and training.
- Represent SP (Early Development) at audits/inspections, Health Authority meetings, and external conferences or consortiums (e.g., CDISC).
Experience and Qualifications:
- Deep understanding of clinical trial methodology, regulatory requirements, and GCP.
- Proven leadership, collaboration, and organizational skills to manage multiple trials effectively.
- BS/MS in life sciences, computer science, statistics, mathematics, or relevant field.
- Fluency in English.
- Early development experience, preferably in Oncology.
- Excellent interpersonal skills for effective operation in a global environment and communication across functions.
- Expertise in SAS or R programming, including development and validation of deliverables and creation of advanced MACROs/functions.
- Experience managing a team of approximately 6-15 programmers.
- May act as a functional/operational manager or individual contributor.
- Advanced knowledge of industry standards, including CDISC, and standard program development.
- Minimum of 2+ years as a Lead/Program/Project Programmer, coordinating large teams, with ideally 10+ years of industry experience and 6+ years in a programming or statistical role.
- At least 3 years of leadership experience.
Why Novartis: Helping people with disease and their families takes more than science. It takes a community of passionate people like you, collaborating and supporting each other to achieve breakthroughs that change lives.
Commitment to Diversity & Inclusion: Novartis is committed to building an inclusive work environment and diverse teams that reflect the patients and communities we serve.
Skills Desired: Classification Systems, Clinical Trials, Data Storage, Programming Languages, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Reporting, Statistical Analysis, Waterfall Model
Assoc Director, Statistical Programming employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Assoc Director, Statistical Programming
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those involved in statistical programming and clinical trials. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in drug development.
✨Tip Number 2
Familiarise yourself with the specific programming languages and tools mentioned in the job description, such as SAS and R. Consider taking online courses or certifications to enhance your skills and demonstrate your commitment to staying current in the field.
✨Tip Number 3
Prepare to discuss your leadership experiences in detail during interviews. Think of specific examples where you successfully managed teams or projects, highlighting your ability to coordinate cross-functional collaboration and deliver results on time.
✨Tip Number 4
Research Novartis and their recent projects in early development, particularly in oncology. Understanding their mission and values will help you align your responses during interviews and show that you're genuinely interested in contributing to their goals.
We think you need these skills to ace Assoc Director, Statistical Programming
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in statistical programming, particularly in clinical trials. Emphasise your leadership roles and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the drug development process and your experience in regulatory activities. Mention specific examples of how you've led teams or projects successfully in the past.
Highlight Technical Skills: Clearly list your expertise in programming languages such as SAS or R, and any experience you have with industry standards like CDISC. This will demonstrate your technical proficiency, which is crucial for the role.
Showcase Leadership Experience: Detail your experience managing teams, including the number of programmers you've overseen and any mentoring or training you've provided. This will help illustrate your capability to lead and develop talent within the organisation.
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've successfully led teams in the past, particularly in statistical programming or clinical trials. Highlight your experience in mentoring and evaluating team members.
✨Understand the Drug Development Process
Make sure you have a solid grasp of the drug development lifecycle and regulatory requirements. Be ready to discuss how your knowledge can contribute to the success of the trials and programs you'll be overseeing.
✨Familiarise Yourself with Industry Standards
Brush up on your knowledge of industry standards such as CDISC and eCTD. Be prepared to discuss how you have applied these standards in your previous roles, especially in relation to statistical programming and reporting.
✨Prepare for Cross-Functional Collaboration
This role requires effective communication across various functions. Think of examples where you've successfully collaborated with other departments or stakeholders. Emphasise your interpersonal skills and ability to build relationships within a global environment.
