Senior Statistical Programmer Lead
2 days ago
We are seeking an experienced Senior Statistical Programmer Lead to join our team. In this role, you will oversee and execute complex statistical programming tasks for pharmaceutical studies.
The ideal candidate will have a strong technical background, excellent leadership skills, and the ability to work collaboratively in a hybrid environment. If you are passionate about statistical analysis and want to make a real impact, we encourage you to apply for this challenging position.
About the Role:
This is an exceptional opportunity to lead a team of skilled professionals and contribute to the development of cutting-edge solutions for the pharmaceutical industry. You will be responsible for ensuring accuracy and compliance with regulatory requirements while managing multiple projects simultaneously.
Responsibilities:
* Perform thorough reviews of protocol, case report forms, annotated case report forms, statistical analysis plan, and mock shell to ensure accuracy and compliance.
* Review specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all deliverables.
* Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells.
* Set up folder structures for assigned studies as per SOPs.
* Forecast team workloads and provide vision on ongoing project objectives/milestones and upcoming projects.
* Provide regular study status updates to Project Managers/ Clients.
* Identify, communicate, and manage study-based risks and issues within timelines to Project managers/Clients.
* Maintain supporting documentation for studies in accordance with SOPs and Work Instructions (WI) to ensure traceability and regulatory compliance.
* Contribute to the development of Statistical Programming standards and processes to improve quality, productivity, and efficiency.
* Stay updated on the latest CDISC Therapeutic standards, GCP, and applicable ICH guidelines.
* Provide guidance, mentoring, and training to junior team members as needed.
* Ensure audit readiness and quality control for all assigned statistical programming deliverables and accuracy of statistical analysis results.
* Verify that team members comply with SOPs and training requirements.
What We Offer:
* Opportunity to work with a talented team of professionals in a dynamic environment.
* Competitive compensation package including salary and benefits.
* Ongoing training and development opportunities to enhance your skills and expertise.
* Collaborative and inclusive workplace culture.
* Flexible working arrangements to support work-life balance.
Requirements:
* Bachelor's degree in Computer Science, Statistics, Mathematics, or related field.
* Minimum 8 years of experience in statistical programming, preferably in the pharmaceutical industry.
* Strong understanding of CDISC standards, GCP, and ICH guidelines.
* Excellent leadership and communication skills.
* Ability to work collaboratively in a team environment.
* Strong problem-solving and analytical skills.
* Proficient in programming languages such as SAS, R, or Python.
* Familiarity with data management systems and tools.
* Experience with version control systems such as Git.
How to Apply:
If you are a motivated and detail-oriented individual with a passion for statistical analysis, please submit your application, including your resume and cover letter, to us.
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