Employment Opportunities:

Manager, Biostatistics– Markham or Bannockburn location

The Manager or Senior Manager of Biostatistics is a tactical and leadership position that reports to the Vice President of Clinical and Regulatory Affairs and is responsible for devising, implementing and managing the statistical activities of multiple pharmaceutical products over all phases of development.  The ideal candidate would be detail-oriented with good organizational, time management and leadership skills, and would possess good communication and interpersonal skills.  Experience with clinical database management systems and activities, and data monitoring plans would be a plus.

Key Responsibilities:

• Contribute in proactively formulating analytical strategies that successfully execute Cytochroma’s core business of pharmaceutical development.
• Participate in clinical and preclinical study designs and protocols, specifically coordinating, facilitating and constructing appropriate statistical analysis plans and CRFs to support the development plan and are consistent with the requirements for regulatory filings
• Maintain expertise in state-of-the-art data manipulation and statistical analyses.
• Develop statistical methodology for studies, including sample size calculations, randomization schemes and strategy, and analysis plan
• Evaluate databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.
• Implementation of protocol methodology and statistical plan to assure timely and accurate, complete and consistent analyses
• Directly or indirectly deliver appropriate, accurate and understandable line listings and statistical tables, and preparation and review of statistical sections of study reports and submission reviews
• Use validated SAS macros, write SAS code, develops program verification procedures and plans to provide thorough and detailed reviews of documentation and analysis output
• Contribute to development of timelines and budgets within multidisciplinary project teams to ensure timely submissions aligned with Cytochroma objectives.
• Supervise review of CRFs to issue queries and clean data as required and direct database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs and ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs
• Develop, interact with, and manage internal employees and external CROs to assure timely and GxP compliant activities to achieve project successes to achieve corporate development plans
• Participate in regulatory submission process, including INDs, CTAs, CTDs, NDAs, serve as statistical interface with the FDA for regulatory submissions and approvals and provide appropriate biostatistical updates to those documents
• Ensure that all documents to be submitted to regulatory agencies are complete, statistically accurate, well-organized and of high quality in such a way as to facilitate review
• Build and maintain good business and working relationships with internal and external groups
• Serves as the statistical contact with outside investigators for participation in advisory boards, in the preparation of scientific presentations and manuscripts and takes a leadership role in process improvement, training, standards development or an area of technical expertise
• Participate in analysis and review of data, and review, edit and contribute to the construction of clinical documents (study reports, publications and summaries) to ensure cGCP compliance and accurate presentation of data
• Provide strategic leadership to identify potential difficulties and strategic execution to implement creative approaches to surmount challenges
• Participate in activities related to potential inlicensing and outlicensing of products
• Mentor and manage activities of statisticians and nonstatistical peers, and provide positive environment to motivate less experienced personnel and communicate statistical concepts to scientists and nonscientists

Requirements:

• MS or PhD in Biostatistics or Statistics or related field
• 3-5 years pharmaceutical industry clinical development experience including support of product approvals and renewals, experience with clinical data management systems would be useful
• In-depth experience with strategic clinical trial planning and analyses that include experimental design, SAS programming, statistical writing and data analysis methodology, biometrics and descriptive and differential statistics that are applicable to meet FDA and ICH guidelines, as well as AMA Style, CONSORT and GPP publication guidelines
• Ability to work independently and as a functional leader and participant in teams
• Approximately 5% travel

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.