Job Overview
Join our esteemed organization as a Senior Manager in Safety Statistical Programming, where you will take on a pivotal leadership role in the field of safety science. This position provides an exceptional opportunity to contribute your programming expertise to the development of pooled safety data sets and to lead a skilled team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products. You will oversee statistical programming activities while ensuring high-quality deliverables and nurturing collaboration across various functional areas.
Key Responsibilities
• Oversee statistical programming initiatives across multiple compounds, indications, and therapeutic areas.
• Mentor and manage a team of statistical programmers, directing resource allocation and project assignments.
• Guarantee timely delivery of high-quality outputs while adhering to established processes and guidelines.
• Harmonize SDTM and non-standard source data across studies by creating and validating ADaM datasets and Tables, Listings, and Figures (TLFs) according to standard operating procedures (SOPs) and project standards.
• Develop and manage SAS programs, integration plans for product safety data, metadata, and ADaM specifications.
• Facilitate collaborative meetings and initiatives involving cross-functional teams, external vendors, and partner organizations.
• Propel the creation of automation tools for data extraction and transformation, including standard SAS Macros, while contributing to cross-functional process improvement efforts.
• Ensure consistency and compliance in ADaM datasets for individual studies and integrated data.
• Prepare necessary documentation for regulatory filings, including reviewer guides and data definition documents.
Required Skills
• Master’s degree in Statistics, Computer Science, or a related discipline with a minimum of 9 years of relevant experience, or a Bachelor’s degree with 11 years of experience.
• At least 2 years of experience in a leadership capacity managing a team of statistical programmers.
• Strong grasp of SAS programming principles and techniques related to drug development.
• Proven experience overseeing multi-study data integration projects and submission programming activities.
• Familiarity with safety analysis activities that support regulatory submissions and safety reports.
• Ability to harmonize clinical study data from varied study designs and standards.
• Extensive knowledge of CDISC Standards and the drug development process.
• Excellent communication skills with a demonstrated ability to foster relationships with diverse stakeholders.
• Strong project management capabilities to effectively organize deliverables and set expectations.
Qualifications
• A Master’s degree in Statistics, Computer Science, or a related area, or a Bachelor’s degree in a relevant field.
Career Growth Opportunities
In this role, you will have the chance to mentor and foster the professional development of your team members, creating career advancement plans that align with their aspirations while also participating in recruitment efforts to build a proficient team.
Company Culture And Values
We are dedicated to cultivating an inclusive environment where diverse perspectives are treasured. We welcome candidates from all backgrounds and are committed to providing equal employment opportunities. Our organization prides itself on its collaborative spirit, respect for individuals, and commitment to innovation.
Compensation And Benefits
This role includes a competitive salary that reflects your experience and expertise, alongside a comprehensive benefits package which consists of:
• Medical, dental, and vision insurance.
• Paid time off.
• A 401(k) retirement plan.
• Eligibility for short-term and long-term incentive programs.
This position allows for remote work within the U.S., offering flexibility while contributing to our mission to enhance patient safety through the development of pharmaceutical products.
Employment Type: Full-Time
Location: North Chicago, IL, US
Offer Expires: 2024-11-04 03:01:47
Job Posting Language: en
Benefits:
- Retirement Savings
- Dental Coverage
- Paid Time Off
- Health Insurance
Qualifications:
- Master's degree in Statistics, Computer Science, or a related discipline with a minimum of 9 years of relevant experience, or a Bachelor's degree with 11 years of experience
- At least 2 years of experience in a leadership capacity managing a team of statistical programmers
- Strong grasp of SAS programming principles and techniques related to drug development
- Proven experience overseeing multi-study data integration projects and submission programming activities
- Familiarity with safety analysis activities that support regulatory submissions and safety reports
- Ability to harmonize clinical study data from varied study designs and standards
- Extensive knowledge of CDISC Standards and the drug development process
- Excellent communication skills with a demonstrated ability to foster relationships with diverse stakeholders
- Strong project management capabilities to effectively organize deliverables and set expectations
Responsibilities:
- This position provides an exceptional opportunity to contribute your programming expertise to the development of pooled safety data sets and to lead a skilled team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products
- You will oversee statistical programming activities while ensuring high-quality deliverables and nurturing collaboration across various functional areas
- Oversee statistical programming initiatives across multiple compounds, indications, and therapeutic areas
- Mentor and manage a team of statistical programmers, directing resource allocation and project assignments
- Guarantee timely delivery of high-quality outputs while adhering to established processes and guidelines
- Harmonize SDTM and non-standard source data across studies by creating and validating ADaM datasets and Tables, Listings, and Figures (TLFs) according to standard operating procedures (SOPs) and project standards
- Develop and manage SAS programs, integration plans for product safety data, metadata, and ADaM specifications
- Facilitate collaborative meetings and initiatives involving cross-functional teams, external vendors, and partner organizations
- Propel the creation of automation tools for data extraction and transformation, including standard SAS Macros, while contributing to cross-functional process improvement efforts
- Ensure consistency and compliance in ADaM datasets for individual studies and integrated data
- Prepare necessary documentation for regulatory filings, including reviewer guides and data definition documents
Benefits:
- In this role, you will have the chance to mentor and foster the professional development of your team members, creating career advancement plans that align with their aspirations while also participating in recruitment efforts to build a proficient team
- This role includes a competitive salary that reflects your experience and expertise, alongside a comprehensive benefits package which consists of:
- Medical, dental, and vision insurance
- Paid time off
- A 401(k) retirement plan
- Eligibility for short-term and long-term incentive programs
LinkedIn: Apply Here