Assoc Director, Statistical Programming

Descripción del trabajo

We are in search of an Associate Director, Statistical Programming to join our team! Statistical Programming– Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.

Key Responsibilities:

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
• Anticipates resource needs.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Directs the design and/or coding of analysis files.
• Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions for multiple therapeutic areas with FDA, PMDA, and other global agencies.
• Has extensive hands-on experience with regulatory submissions including integrated analysis and post-submission activities such as FDA and PMDA filing, RtQs, AdCom preparation, and inspections.
• Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
• Has the proven ability to anticipate and resolve study related issues and conflicts within a therapeutic project.
• Proven track record as a key resource on multiple, time-sensitive, and complex tasks
• Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines.
• Manages critical deadlines, demonstrates ability to resolve issues, and ensures tasks will be completed within designated timeframe.
• Identifies and leads strategic initiatives for the programming group.
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Basic Qualifications:

BS degree in Biostatistics/Computer Science or equivalent and 10+ years’ experience in pharma/biotech -OR -

MS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech –OR -

PhD degree in Biostatistics/Computer Sciences or equivalent 3+ years of experience in pharma/biotech

Preferred Qualifications:

Degree in Biostatistics/Computer Science or equivalent

• 10+ years of pharmaceutical/CRO experience

• Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred.

• Submission knowledge is strongly preferred.

• Extensive hands-on experience in pivotal studies, integrated analysis, and other regulatory submission related activities.

• In-depth understanding of clinical programming and/or statistical programming processes and standards

• In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)

• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros

• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)

• Proven experience in complex and fast turnaround programming activities

• Excellent interpersonal, communication, problem solving, and analytical skills