Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Principal/Sr. Principal Statistician in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal/Sr. Principal Statistician, you will be empowered to provide statistical leadership and work in complex programs, and a typical day will include:
OBJECTIVE: Position is to provides compound level / development phase statistical expertise and leadership by:
- Provide statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level with complex programs
- Promote innovative design and analysis methodology.
- Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
- Improving and using standards to maximize global data integratability, interpretability and compound level efficiency
- Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.
- Independently representing Statistics function in interactions with regulatory authorities.
- Actively participate in and contribute to decision making related to clinical development strategies, regulatory strategies, and commercial strategies.
- Promote innovative design and analysis methodology
- Provide statistical leadership in design, analysis, and interpretation of clinical studies at a compound level with large complex programs.
- Independently represent statistics function on global teams in support of clinical studies and compound level programs.
- Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions. Negotiate timelines (statistical) at compound level.
- Plays a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
- Oversee definition and implementation of compound-level database (including derived database), analysis and reporting standards. Improve or use existing standards to ensure maximization of global integratibility and interpretability of data and enhance efficiency at compound level. Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at compound level.
- Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
- Identify compound level vendor requirements and participate in the evaluation/selection of vendors. Provide compound level analytical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
- Identify and interact with external statistical experts for issues related to study design, methodology and results.
- Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
- Lead the implementation of department standards and process improvements.
- Lead evaluation and implementation of alternative analysis methodology and data presentation techniques.
- Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a compound level.
EDUCATION, EXPERIENCE AND SKILLS:
- PhD in statistics or biostatistics with at least 6 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with at least 10 years of relevant pharmaceutical industry experience.
- Experience with at least one NDA/CTDs or other global regulatory submissions.
- Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
- Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
- Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
- 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).
- Excellent oral and written communications skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a cross-functional team.
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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.