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Associate Director, Statistical Programming (301-419)

ARIAD Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 5/2/2013 Position Type: Full time Job Code: 301 Salary: DOE Required Education: Other Areas of Expertise Desired: Other

Description



ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary:

Provide oversight and technical leadership for statistical programming, within the biostatistics and statistical programming team. The biostatistics and statistical programming team is part of the Biomedical Data Sciences and Information department.

Responsibilities:

- Manage a team of experienced, technical statistical programmers to carry out programming required for analyses of clinical trial data
- Oversee preparation of submission data packages compliant with regulatory standards
- Manage vendor/CRO relationships for activities specific to programming function
- Provide technical guidance to staff
- Liaise with other functions including data management to develop efficient processes for standardization and delivery of clinical data and clinical data review tools
- Identify and lead initiatives to improve quality, productivity and infrastructure of statistical programming group (e.g., standardization, use of new techniques, quality control processes)
- Manage programming resourcing needs
- Lead efforts to maintain existing and develop new SOPs specific to statistical programming
- Liaise with IT function as needed for management of SAS software
- Maintain knowledge of FDA regulations, new programming and database technologies and standards
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements



- At least 10 years of statistical programming experience in the pharmaceutical/biotechnology industry or CRO setting, including at least 4 years of management experience
- Experience with NDA/BLA filings
- Experience in development and implementation of SAS programming standards and conventions
- Strong leadership and communication skills
- Master’s degree in mathematics or statistics is a plus
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.
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