Associate Director / Director, Statistical Programming
Title: Associate Director / Director, Statistical Programming
Job Summary: The Associate Director / Director of Statistical Programming will lead and oversee all statistical programming functions, ensuring the delivery of high-quality support for clinical trials and regulatory submissions. This role involves strategic planning, resource management, and collaboration with cross-functional teams to achieve team and company-wide goals. *This candidate will be the sole Statistical Programmer on the team*
Key Responsibilities:
- Oversee the planning, execution, and delivery of statistical programming projects, ensuring timelines and quality standards are met.
- Develop and implement programming standards, guidelines, and best practices. Ensure compliance with regulatory requirements and industry standards.
- Work closely with biostatisticians, data managers, and other stakeholders to ensure seamless integration of statistical programming activities within clinical trials.
- Lead the preparation and review of programming deliverable for regulatory submissions, ensuring accuracy and completeness.
Qualifications:
- Masters in Statistics, Biostatistics, Computer Science, or a related field (Preferred)
- Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry
- Proficiency in SAS, R, and other statistical programming languages.
- Strong understanding of CDISC standards (SDTM, ADaM).
- Demonstrated experience in leading a clinical asset through all phases of development
- Proven expertise in regulatory submissions, including leading and managing submission processes
Location:
- 3 days a week on-site in the Greater Philadelphia Area.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.