Posted to MedZilla on 3/25/2017


Takeda Pharmaceuticals

US-MA, Associate Director / Director Safety Statistics and Research Analytics 1700193-MZ


 
 

OBJECTIVES:
  • Leads and organizes a Pharmacovigilance Support team to provide statistical and programming expertise and capability in support of pharmacovigilance activities for global development projects and marketed products.
  • Drives statistical strategy for ongoing safety evaluations and pharmacoepidemiologic research to support multiple therapeutic areas.
  • Oversees all pharmacovigilance support activities for assigned therapeutic areas to ensure timely and accurate preparation of safety analysis databases, safety analyses, and data presentations.
  • Establishes and drives global functional strategy related to resourcing, technologies, processes and standards to maximize efficiency and global data integratability.

ACCOUNTABILITIES:

  • Leads by setting organizational strategies, goals, and priorities aligned with the business needs and strategies of Takeda.
  • Supports achievement of major reporting deliverables and milestones in coordination with Pharmacovigilance and Medical Writing:
  • Defines cross-study safety data integration and analysis strategies.
  • Generates safety analyses and reporting outputs for regulatory submissions.
  • Ensures documentation and archival of statistical programming deliverables including analysis databases, summaries, programs and specifications.
  • Drives statistical strategies for ongoing safety evaluations and signal detection for assigned therapeutic areas to minimize potential risk.
  • Drives development and implementation of global signal detection tool, processes and standards (including coordination with Japan) to provide standardization, ensure timely report, and maximize quality and efficiency.
  • Provides support for post-marketing safety.
  • Provides access to internal and external statistical and statistical programming expertise and capacity to support assigned projectactivities:
  • Selects, manages and develops staff.
  • Manages internal capacity in collaboration with Global Statistics and Statistical Programming departments to effectively support global development projects and marketed products.
  • Effectively leverages external statistical and programming capabilities (vendors and expert consultants).
  • Contributes to development of Analytical Sciences vendor strategy and provides oversight of statistical programming services for pharmacovigilance support provided by global strategic partner CROs.
  • Provides input for planning and management of external budgets related to safety support deliverables. Assist the Sr. Director to plan and manage internal administrative budget for the Pharmacovigilance Support function as needed.
  • Ensures that appropriate training and education programs are in place to develop personnel to help achieve functional goals and long-term strategy.
  • Represents function in external professional initiatives and organizations such as SUGI, ASA, DIA, etc. to increase identify industry best practice and increase the visibility of Takeda.
  • Ensures compliance of function with Takeda SOPs, standards and all applicable regulations.
  • Other duties as assigned.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • MS or PhD in Statistics, Biostatistics, Computer Science or related analytical field.
  • 10+ years experience in the pharmaceutical industry and/or clinical research supporting clinical trials including multiple NDA/CTD submissions.
  • 5+ years experience supporting safety evaluation for development projects and/or marketed products.
  • 5+ years of line management experience.
  • Proven track record in identifying and implementing organization-wide initiatives.
  • In-depth knowledge of statistical analysis methodologies and reporting procedures for safety evaluations.
  • Good knowledge of statistical programming languages (including SAS), software, techniques, and processes.
  • Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products).
  • Active in statistical/statistical programming/pharmaceutical professional organizations.
  • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the safety evaluation of development projects/marketed products.Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces.

PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to sit and stand for long periods of time.
  • Carrying, handling and reaching for objects.
  • Ability to lift and carry over 25 pounds.
  • Manual dexterity to operate office equipment i.e. computers, phones, etc.
TRAVEL REQUIREMENTS:
  • Access to transportation to attend various meetings held in proximity to the Takeda offices.
  • Able to fly to various meetings at investigator, vendor or regulatory agency sites.
  • Some international travel may be required.


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