Senior Director of Biostatistics

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Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Senior Director of Biostatistics in Laval, Quebec. This position will serve as the lead statistician and is accountable for all statistical aspects for the assigned compound’s development throughout development phases and regulatory filing activities. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities

• Lead the biostatistics function to develop and execute statistical strategy, design, and analyses for clinical trials and development programs
• Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
• Help design data capture methods and select appropriate study endpoints for clinical programs
• Attend meetings with regulatory agencies and support/defend clinical programs
• Oversee statistical vendor’s deliverables and accountable for timely and high-quality delivery of all biostatistics deliverables including quality statistical analysis plans and statistical output
• Oversee the production and interpretation of TLFs from draft to final to ensure quality of programming and data
• Supervise internal and external statistical resources to achieve company goals
  

Experience

• Minimum of 10 years of experience with at least 3 years of supervisory experience preferred
• Background in Respiratory preferred
• Experience working with statistical vendors preferred
• Experience in contributing to NDAs/BLAs submission and defense required
• Proficient SAS programming skills and solid understanding of CDISC models, and standards
• Excellent writing and communication skills, demonstrated leadership abilities, and excellent interpersonal skills
• Solid knowledge in drug development across phases and updated understanding about health authority guidelines
• Ability to conduct independent research and resolve statistical methodological issues
• Solid knowledge about statistics especially in clinical trial design and data analyses
• Rich experience of applying appropriate statistical methodology in solving real problems and in making drug development to be more efficient and successful
• Demonstrated effectiveness working with multi-functional team members to deliver common goals
  

EDUCATION

• Minimum of Bachelor’s Degree in science or a related discipline required
• Ph.D. preferred
  

To Be a Best-fit Your Strengths Must Include

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

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