Director, Statistical Programming - San Diego, CA

Summary

We seek a talented Director, Statistical Programming who will serve as lead statistical programming support for multiple clinical development programs and studies, including analysis pertaining to study statistical analysis plans (e.g., primary/secondary/exploratory efficacy and safety endpoint analyses), ad hoc analysis, safety-related analyses/reports, abstracts/publications, regulatory submissions (e.g., Data Safety Update Reports), statistical program validation, and exploration of new technologies to improve the productivity of statistical programming department. The individual will oversee contract research organization (CRO) deliverables to ensure high quality data, outputs, and submission and will collaborate with and/or manage contract programmers as necessary. This hands-on position requires comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and the drug development process. This person is expected to ensure that the clinical statistical programming elements are in line with the overall deliverables and to ensure adherence to Good Programming Practices, ICH guidelines, and regulatory requirements. This position reports to the Senior Vice President, Biometrics.

Responsibilities

• Executes and leads the oversight of statistical programming activities with the aim of providing high quality outputs, submission data, and deliverables, all the while complying with corporate and regulatory requirements.
• Provide technical expertise for the development of programming standards and procedures.
• Collaborating with Biostatistics in the creation, implementation, and maintenance of programming development plans for each project. Account for timelines and quality deliverables for all project work assigned, ensuring that all programming has been conducted per industry and internal standard practice.
• Collaborating with Data Management to implement the CDISC standard at the CRF and database build-up stage.
• Supporting and overseeing projects for the creation of analysis datasets (e.g., SDTM/ADaM), production/validation of output, review of annotated case report forms, and review of electronic submission components including Define.xml, Reviewer's Guides, and Pinnacle 21 reports.
• Contributing to process and standards initiatives such as CDISC.
• Leading the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.
• Overseeing the work of internal and/or contract programmers, providing guidance, and mentoring programmers in statistical programming methodologies.
• Supporting clinical trials with ad-hoc analysis requests, data validation, and other requests in accordance with all relevant statistical regulatory guidance and standards.
• Collaborating with Medical Writing, Clinical Development, and Regulatory Affairs on study- or program-related projects and initiatives.
• Other duties as assigned.
• Contributes to the development of departmental policies, standards, and process improvement initiatives.

Experience and Qualifications

• Bachelor's degree required, MS or doctorate degree preferred.
• 10 or more years statistical programming experience in pharmaceutical and/or biotechnology, may consider relevant contract research industry experience.
• 5 or more years of direct/indirect management experience preferred.
• Demonstrated experience selecting/managing statistical programming CROs and vendors.
• Experience in the development and implementation of statistical programming standards and procedures is required.
• Experience using industry standards such as CDASH, SDTM, and ADaM for regulatory submissions required.
• Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language, and SAS SQL; SAS/GRAPH a plus (SAS version 9 or higher).

Skills and Abilities

• Proficient in developing own SAS code as well as modifying existing code required.
• Experience leading statistical programming projects and supporting NDA and EMEA filings.
• Flexible to changing priorities, detail-oriented, works well under pressure with an initiative to take on unfamiliar tasks.
• Knowledge of Good Programming Practice, Good Clinical Practice (GCP), ICH, and Regulatory requirements.
• Demonstrated ability to develop, communicate, negotiate and implement solutions to data issues and processes to yield more accuracy and greater productivity.
• Anticipates potential challenges within a clinical study and creates contingency plans accordingly. Elevates potential changes/risks to team and leadership.
• Demonstrated ability to handle high volumes of work in a fluid, dynamic, and fast-paced environment.
• Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines.
• A commitment to collaborative leadership, management, teamwork, delegation, and a professional culture based on trust and mutual respect.
• Excellent interpersonal, reading, writing, communication and public presentation skills, along with exceptional organizational skills.
• Successful track record of working in a matrixed organization and building strong relationships with other functions and contractors/vendors.
• Strong problem and conflict-resolution skills.
• Exceptional business acumen, analytical skills.
• Ability to develop and manage expenditures in accordance with budget.
• Travel up to 10%.

The expected base pay range for this position is $175,000 - $225,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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