Executive Job Title	Director, Biometrics
Type of Registrant	Recruiter
Location	New Jersey
Industry & Function 1:	Biotechnology - TECHNOLOGY(IT/EDP/MIS/Communications)
Industry & Function 2:	Pharmaceuticals(Ethical)/Surgical/Medical-Equip. - TECHNOLOGY(IT/EDP/MIS/Communications)
Compensation	$100,000 to $200,000
Executive Job Description	Employment Opportunity Director, Biometrics Position reports to: Vice President, Clinical Operations Responsible for SAS programming leadership and statistical support for US and EU regulatory submissions inclusive of resource planning and allocation, review and contribution to clinical trial SAP and derived datasets. At the request of senior management, may represent the Company at the FDA for Pre-NDA meetings and FDA advisory board meetings. Additional Responsibilities: • Participate and contribute in clinical development content meetings and turn decisions into actions and deliverables by the SAS programming and statistical groups • Provide SAS programming leadership for US and EU regulatory submissions, inclusive of resources planning and allocation in the face of competing priorities, identification and implementation of programming efficiencies in the integrated database and TFL’s • Provide performance management of internal and external programming resources against target submission dates which includes timeline management of submission datasets and TFL’s, engaging key stakeholders in timeline discussions, setting expectations and acceptance criteria of external vendors contributing to the clinical development effort • Manage budgets to maximize the ROI of external vendors and limiting the out-of-scope work of external vendors • Lead initiatives to ensure submission is of reasonable quality through edit check verification, database integrity, dry run of submission TFL’s and review by internal customers of submission of TFL’s • Provide statistical support for US and EU regulatory submissions, inclusive of review of and contribution to clinical trial SAP and derived datasets to ensure that aspects of the SAP and derived datasets are able to be implemented from a programming aspect and that they are practical and feasible • Contribute to identifying and overcoming obstacles brought on by different data in the integrated database and work with internal staff and clinical development content leadership to resolve these issues • Provide overall leadership to direct manager level reports, including mentoring and guiding subordinates and prioritizing workload and project assignments Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. Qualifications: • PhD in Biostatistics or Statistics with 8 years of relevant experience or an advanced degree in Biostatistics or Statistics with 12 years of relevant pharmaceutical industry experience • 15 years of management experience or an equivalent combination of training and experience • Familiarity with most statistical methods that apply to Phase II and Phase III clinical trials • Knowledge and experience in clinical development specific analyses from a statistical and programming perspective • Extensive programming knowledge of SAS • Knowledge of ICH guidelines relating to regulatory submissions and experience in leading an eCTD submission (US and Europe) • Travel may be required
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