110 applicants

Company

Daiichi Sankyo, Inc. · 1 week ago

Director Statistical Programming

United States

Full-time

Remote

Director/Executive

10+ years exp

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Health CareTherapeutics

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority’s requirements. Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to ensure proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE).

Direct Project Support: Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers.

CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of budget, resources, and timelines for contract research organizations (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.

Global Health Authority Interaction / Negotiation: Reviews documents and responses submitted to health authorities globally with respect to data standards, compliance, etc. May represents the function at health authority meetings. Reviews and provides input to TLF shells for submission documents (e.g., ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.

Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice, especially with respect to oversight of vendor performance. Oversees compliance with standard procedures and processes. Leads the development and refinement of analysis data standards for AML as well as solid tumor studies.

Leadership of Strategic Initiative and Cross-Functional Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management. Works with colleagues at DST and DSE to identify opportunities for global harmonization and process improvement.Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc.

Qualification

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CDISCStatisticsProject ManagementNDA SubmissionBLA SubmissionADaMSDTMData ManagementRegulatory Compliance

Preferred

Bachelor's Degree an accredited institution in a science or in a technical field preferred

Master's Degree preferred

10 or More Years experience (Bachelor 12 or More Years) in pharmaceutical industry preferred

Thorough understanding and proficiency of CDISC. preferred

Advanced knowledge of CDISC requirements for SDTM and ADaM. preferred

Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred

Working knowledge in statistics as measured by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred

Strong project management experience and ability to manage and execute multiple projects and deadlines. preferred

Company

Daiichi Sankyo, Inc.

Glassdoor

4.0

At Daiichi Sankyo, we create essential medicine for longer, better lives.

Founded in 2010

Basking Ridge, New Jersey, USA

10,001+ employees

https://daiichisankyo.us

H1B Sponsorship

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2020 (8)