Associate Director, Statistical Programming - Princeton, NJ
Associate Director, Statistical Programming - Princeton, NJ
VetJobs
Princeton, NJ
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Project Responsibilities
Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
Drives the development and implementation of innovative strategies and technologies for clinical trial programming
Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
Leads the electronic submission preparation and review
Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
Reviews planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
Improvement Responsibilities
Drives, Identifies, leads, and supports opportunities to enhance processes and technology
Communicates proactively and effectively around issues and risks and contributes to its remediation
Managerial Responsibilities
Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains direct reports, resulting in an increasing level of capabilities within GBDS
Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager
Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
Communicates with manager regarding promotions, performance concerns, and retention risks
Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results
Act as extended member of Statistical Programming Leadership Team in sharing and building up the line function vision
Auto req ID
422650BR
Minimum Education Required
Bachelors
Job_Category
Director
Additional Qualifications/Responsibilities
Minimum Requirements:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 10 years programming experience in industry including support of significant regulatory filings and minimum 5 years of experience in managing technical professionals in a regulated environment
For US positions: US military experience will be considered towards industry experience
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
Broad expertise in statistical programming and in developing computing strategies
In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)
Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)
Demonstrated ability to work in a team environment with clinical team members
Preferred Requirements
Member of industry organizations or presented at Congresses/Conferences
City*
Princeton
State*
New Jersey
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Project Responsibilities
Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
Drives the development and implementation of innovative strategies and technologies for clinical trial programming
Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
Leads the electronic submission preparation and review
Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
Reviews planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
Improvement Responsibilities
Drives, Identifies, leads, and supports opportunities to enhance processes and technology
Communicates proactively and effectively around issues and risks and contributes to its remediation
Managerial Responsibilities
Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains direct reports, resulting in an increasing level of capabilities within GBDS
Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager
Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
Communicates with manager regarding promotions, performance concerns, and retention risks
Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results
Act as extended member of Statistical Programming Leadership Team in sharing and building up the line function vision
Auto req ID
422650BR
Minimum Education Required
Bachelors
Job_Category
Director
Additional Qualifications/Responsibilities
Minimum Requirements:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 10 years programming experience in industry including support of significant regulatory filings and minimum 5 years of experience in managing technical professionals in a regulated environment
For US positions: US military experience will be considered towards industry experience
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
Broad expertise in statistical programming and in developing computing strategies
In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)
Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)
Demonstrated ability to work in a team environment with clinical team members
Preferred Requirements
Member of industry organizations or presented at Congresses/Conferences
City*
Princeton
State*
New Jersey
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
-
Seniority level
Director -
Employment type
Full-time -
Job function
Marketing, Public Relations, and Writing/Editing -
Industries
Armed Forces
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