Associate Director of Statistical Programming

Associate Director of Statistical Programming

06 Jun 2024
New Jersey, Princeton 00000 Princeton USA

Associate Director of Statistical Programming

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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.ResponsibilitiesProject Responsibilities

Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with BDS’s software development lifecycle procedures

Provides comprehensive programming leadership and support to clinical development teams

Ensures quality of BDS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices

Drives the development and implementation of innovative strategies and technologies for clinical trial programming

Develops unambiguous and robust programming specifications for internal and external programming work

Provides technical guidance to statistical programmers and vendors around project conventions, standards, practices, and specifications to ensure integrated computing solutions

Reviews planning documents (e.g. statistical analysis plans, data presentation plans, data review plans) to ensure clarity, integrity and compliance with requirements and standards

Managerial Responsibilities

Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains 3-5 direct reports, resulting in an increasing level of capabilities within BDS

Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with the Director of Statistical Programming of ICF

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 Director of Statistical Programming of ICF 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.

Models acceptable behaviors and communication with stakeholders to ensure effective partnerships

Serves as a point of escalation for technical, operational and staffing issues which are unable to be resolved at the team level

Enables a culture of inclusiveness, respect for diversity, compliance with processes; encourages the questioning and challenging of others in a respectful and constructive manner

Identifies, leads, and supports improvement initiatives within BDS and serves as a BDS representative on cross-functional initiatives

Qualifications

Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience

Minimum of 10 years of clinical/statistical programming experience within pharmaceutical clinical development with experience that includes leading programming efforts to support regulatory filings (e.g. US, EU, Japan)

Minimum 5 years of experience in managing technical professionals in a regulated environment

Extensive knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing techniques in addition to knowledge of R or other statistical software packages

Significant knowledge of the drug development process, clinical trial methodology, statistics and relevant regulatory requirements for drug approval

Demonstrated ability to operate and lead in a matrix organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.

Able to adapt quickly to the changing needs of the organization

Able to organize multiple work assignments and establish priorities

Excellent verbal and written communications skills; able to communicate proactively and effectively

US military experience shall be considered towards industry and professional experience requirements.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 the resources to pursue their goals, both at work and in their personal lives.Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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  • Overview

  • Senior Manager, Statistical Programming (Princeton, NJ)Responsible for leading and participating in the development and validation of datasets, tables, listings, and figures (TLFs) that support the analysis and reporting of clinical trials and for providing expertise for statistical programming activities. Develop collaborative relationships and work effectively within the Statistical Programming team, with cross-functional teams, and external vendors. Create SAS programs to generate derived analysis datasets and TLFs.Perform programming validation to ensure quality of analysis datasets and TLFs. Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.Provide analysis programming, including generating reports, tables, listings, graphs, statistical analyses, and applications to satisfactorily fulfill requirements.Work with team members to develop new macros and programs to simplify and execute daily tasks efficiently. Lead and/or support submission preparations, deliverables, and regulatory responses.Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess impact on programming activities.Collaborate with other function managers and Otsuka departments (i.e., Safety, Medical Writing, Clinical, Biostatistics, and Quality Management) to ensure that their requirements are satisfactorily fulfilled.Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers.Provide leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and working practices.Identify opportunities for increased efficiency and consistency within Statistical Programming, Clinical Analytics, and interactions with vendors.Develop Clinical Programming Group training manuals to promote standard processes and procedures. Minimum Requirements:Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Analytics, Chemistry, Pharmacy or related life science field.Six (6) years of experience with SAS programming.Six (6) years of experience in developing statistical base programming and database management.Six (6) years of experience with relational database structures.Six (6) years of experience with CDISC standards and relational database structures.Six (6) years of experience with regulatory, industry, and technology standards and requirements.Six (6) years of experience with the drug development process, clinical trials, medical terminology, statistical analysis plans and protocol designs.Four (4) years of relevant experience in the pharmaceutical industry.Four (4) years of experience providing outputs to meet submission requirements such as ADaM datasets, define files and reviewer’s guides.Interested candidates should contact Missy-Zahler-CW@otsuka-us.com, Otsuka Pharmaceutical Development & Commercialization, Inc.

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