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Associate Director, Statistical Programming
Our client is searching for a creative, resourceful, integrative thinker for an important role as the Associate Director, Statistical Programming. This individual will collaborate with project biostatisticians, clinical data managers, CRO vendors, and other colleagues in the creation, implementation, and maintenance of statistical programming deliverables for each project. The candidate will lead the effort to continuously improve processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives. This individual will also represent the Statistical Programming function of the Data Science group within inter-departmental meetings and committees.
- Provide leadership and support to project teams on all statistical and data programming matters according to the projects’ strategies.
- Communicate regularly with CRO vendors to ensure quality and on-time delivery and with members of various internal teams (Data Science, Medical Science, and Program Development) to provide delivery-related updates.
- Lead projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval, and post marketing support.
- Lead design, development, and validation of CDISC ADAM submission packages.
- Lead and collaborate across functions for the identification and development of programming standards and macros to facilitate the creation of statistical deliverables, as well as in process improvement activities to ensure high quality and timely statistical programming deliverables.
- Ensure compliance to internal standards and work with Data Science management to identify resource needs based on project milestones and deliverables.
- Act as mentor to junior staff with regard to programming techniques, project management, and implementation of standards.
- Contribute to the recruitment process for programmer positions within the department, both contract and permanent.
- Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.
- Develop data models, programming standards, and codes as well as train end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
- Maintain knowledge of new technologies, industry standards, regulatory requirements, and CSO guidelines and SOPs. Implement the quality control procedures that are operationally optimized and in compliance with regulatory requirements.
- Support department initiatives and task forces. Lead/participate in departmental or cross-functional working groups and process improvement activities.
- Assist in resource assessments based on in-depth project knowledge, milestones, and deliverables. Implement global resourcing strategy with regard to the use of off-shore operations, outsourcing, and insourcing.
- Effectively interact with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.
Requirements / Qualifications:
- MS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 12+ years of programming experience in the pharmaceutical industry, or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 15+ years of programming experience in the pharmaceutical industry.
- Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
- Excellent knowledge of clinical trial research methodologies, CDISC, ICH, GCP, and 21 CFR Part 11 rules and regulations.
- Experience in ad-hoc programming to produce analysis for various analysis in a short timeframe.
- Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
- Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution-oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Excitement about the vision and mission of the company
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
- Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.