Associate Director, Biostatistics

San Diego, CA

Perm Salary

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as an Associate Director, Biostatistics. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 


RESPONSIBILITIES

  • Serves as functional leader within biostatistics; liaises frequently with product strategy teams and communicates plans and strategy to department and subordinates
  • Directs activities for selection of appropriate statistical methods for analysis of clinical study data; provides input into clinical development plans, approves all protocols, statistical analysis plans, and case report forms to ensure adequate control and design of studies
  • Accountable for the final statistical analysis plan for all studies conducted by company. Responsible for ad hoc reporting and meta-analyses
  • Responsible for interacting with FDA personnel on clinical trial statistical issues and data presentations
  • Reviews regulatory documents such as CSRs, as well as summary documents
  • Directs outsourcing activities in collaboration with preferred vendors
  • Provides strategic and tactical input in the contracting with Global Biometrics preferred providers
  • Consults with the Project Team Members on the interpretation of efficacy results
  • Contributes to the publication plan. Authors and reviews abstracts, posters, and manuscripts to support Medical Affairs
  • Key member of Submissions team
  • May lead departmental process improvement initiatives and contribute to SOPs

EXPERIENCE

  • Minimum three to five years’ industry experience in clinical/medical research, but generally has 5-8 years of highly relevant experience
  • Strong background and working knowledge of statistical methods that applies to all phases of clinical trials
  • Must have a working knowledge of statistical analysis plans including the report outline, mock-up tables, graphs and data listing shells and appendices
  • Must have a working knowledge of all appropriate relevant regulatory guidance (e.g. ICH, FDA and EMEA)
  • Direct submission/filing experience is preferred. Submission experience outside of the US is an asset
  • Proficiency in SAS and nQuery software packages. Knowledge of CDISC requirements
  • Ability to program if needed, oversees programming work performed by staff or vendors
  • Ability to determine appropriate designs and analyses for clinical trials
  • Ability to respond to regulator’s inquiries for products undergoing registration and approved products
  • Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed
  • Ability to help others understand the broader business and organizational context (inspiring and motivating others)
  • Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
  • Demonstrated ability to reinforce a culture in which partnering is a norm

EDUCATION

  • MS or Ph.D. in Statistics/Biostatistics or closely related field (oncology experience 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.

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