Career Opportunities

Director, Biostatistics and Programming

Description of Duties:

The Director of Biostatistics and Programming leads and directs the activities of the Biostatistics and Programming Groups, including interactions with external biostatisticians (contract research organizations and consultants). The Director is responsible for ensuring that all Biostatistics and Programming activities are conducted in compliance with Sangart standard operating procedures (SOPs) and applicable regulatory agency guidances and regulations. The Director provides statistical and programming support to assist Data Management as needed

• Provides statistical leadership to product and project teams within Sangart.
• Directs the activities of biostatisticians, statistical programmers and medical writers. Provides technical leadership and mentoring to department staff.
• Responsible for selection of appropriate statistical methods for analysis of clinical and non-clinical data.
• Collaborates with medical, clinical, research colleagues on the interpretation of safety and efficacy results and presentation.
• Ensures that all Biostatistics and Programming members are trained on all relevant SOPs, and ensures that all Biostatistics and Programming activities are conducted in compliance with these SOPs and with all applicable guidances and regulations.
• Ensures the quality and timely completion of Biostatistics, Programming, and support to Medical Writing.
• Provides technical writing when necessary, review and approval for Clinical Trial Reports, Statistical Analysis Plans, Interim Analysis Plans, Data Management Plans, Randomization Plans, and New Drug Applications and other regulatory documents, manuscripts, and data included in posters and presentations.
• Provides technical support for Sangart strategic planning and project feasibility, such as product development plans, post-marketing safety assessment strategies, and resource allocation for information technology requests.
• Attends FDA, MHRA, and any other agency meetings and conference calls when necessary and ensures that all FDA and other agency requests for information are completed in a timely manner.
• Pursues opportunities for using Biostatistics and Programming technical expertise for projects conducted by other Sangart departments, such as Product Development and Manufacturing, Regulatory Affairs, Information Technology, Sales and Marketing.
• Participates in the review of in-licensing candidates as needed; provides advice regarding supporting clinical trial designs, and for the interpretation of the associated statistical analysis results.
• Ensures adequate department resourcing; control of departmental budget, and provides recommendations for hiring and outsourcing.
• Provides professional growth opportunities and career development to members of Biostatistics and Programming.

General Duties:

• Other duties as assigned by the VP of Clinical Development, VP of Regulatory Affairs, Chief Medical Officer, and/or Chief Executive Officer.

Job Qualifications:

• A PhD (desired) or MS degree (required) in Biostatistics or Statistics
• At least 10 years of relevant industry experience, with a minimum of 5 years in a biotech or pharmaceutical research environment if other experience is at a CRO
• Experience with variety of analytical techniques, method development and validation. (HPLC, GC, UV, FTIR, Karl-Fischer moisture analysis;LCMS, GCMS, NMR experience is a plus)
• Excellent interpersonal skills and effective oral and written communication skills.
• Effective team building and leadership skills.
• Ability to address complex problems to determine appropriate designs and analyses for clinical trials.
• Experience to address unique needs of non-clinical study design and numbers of subjects for statistical analyses in regulatory submissions and journal publications.
• Ability to think strategically, at the departmental and the organizational levels.
• Ability to interact with other company departments, and to identify areas where Biostatistics and Programming technical expertise can be effectively used.
• Experience interacting with regulatory authorities including formal response to queries, preparation of statistical sections of briefing documents, and generation of scenarios for advisory meetings.
• Proficiency and experience with drafting, editing and QC of clinical study reports, and statistical sections and data presentations for regulatory submissions and external publications.
• Experience with NDA or BLA assembly and submissions.
• Proficiency with SAS including ability to program or validate programming.
• Experience with set-up, execution and close-out of clinical studies using Electronic Data Capture systems, (example: Medidata RAVE, Phase Forward InForm, etc.)
• Experience with Clinical Data Interchange Standards Consortium (CDISC) and Clinical Data Acquisition Standards Harmonization (CDASH) conversion process.
• Experience implementing Study Data Tabulation Model(SDTM) and Analysis Data Model(ADaM) standards.
• Experience with the development of project plans, timelines and budgets.
• Experience with CRO oversight and management, serving as primary interface for external vendors/contractors in statistics and/or programming.
• 4+ years of supervisory experience with effective management skills.