Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Statistics, PRO & Benefit-Risk Assessment in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The Associate Director is responsible for assisting the Director, Statistics with management and leadership of biostatistics-related activities in the area of Patient Reported Outcomes (PROs), other clinical outcome assessments, and benefit-risk assessment. Contributes to PRO and benefit-risk strategy, and serves as a statistical expert in registration and communication activities. Represents Takeda and provides input to his/her supervisor for statistical issues in communications with regulatory authorities. Reviews regulatory documents such as protocols and Clinical Study Reports, as well as summary documents.
- Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; provides input into clinical development plans.
- Contributes to PRO section of protocol and SA. Reviews statistical outputs. Primary author of the PRO section of study reports for study and integrated reports.
- Contributes to structured benefit-risk documents. Applies methods such as multi-criteria decision analysis (MCDA).
- Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
- Reviews regulatory documents such as CSRs, as well as summary documents.
- Consults with the Medical Writer and Physician on the interpretation of PRO results and the outputs of benefit-risk analysis. Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs.
- Leads or contributes to departmental process improvement initiatives and development/revision of SOPs.
- Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs.
- Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Statistical & Quantitative Sciences (SQS) preferred providers.
CORE ELEMENTS RELATED TO THIS ROLE:
- Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices.
- Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA).
- Direct regulatory filing experience is required.
- Proficiency in SAS is strongly preferred. Proficiency in R is desired.
- Experience with PROs and other clinical outcome assessments in clinical trials is preferred.
- Experience with benefit-risk assessment techniques such as MCDA is desired.
- 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)
- Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer’s decision-making process (serving customers)
- Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
- Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
- Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
- 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- M.S. in Biostatistics or closely related field is required.
- Ph.D. in Biostatistics or closely related field is strongly preferred.
- Generally has 8+ years of relevant pharmaceutical experience.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
This posting excludes Colorado applicants.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.