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 Senior Statistician in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Statistician working on the team, you will be empowered to provide statistical support to real-world data research, digital solutions and artificial intelligence, and a typical day will include:
- The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:
- Provide statistical support to real-world data research, digital solutions and artificial intelligence/machine learning projects
- Independently designing, analyzing and interpreting clinical or observational studies at a compound level for early phase or less complex programs.
- 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.
- Independently represent statistics function on global teams in support of clinical or observational studies and compound level programs.
- Provide statistical support to platform development, indication expansion and external control arm development
- 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, 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: (List the education and experience required to perform the primary responsibilities of the job. Equivalent combinations of education and experience should be noted).
- PhD in statistics or biostatistics with at least 3 years of relevant experience or MS in statistics or biostatistics with at least 6 years of relevant experience.
- Advanced knowledge of observational databases such as claims and EHR databases.
- General knowlowdge of indirect comparison and artificial intelligence/machine learning.
- Extensive experience in conducting real world data analyses using SAS and R
- Experience with advanced study design or at least one NDA/CTDs or other global regulatory submissions.
- Advanced knowledge of clinical or observational 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 or observational research, 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 OfficeÒ products).
- Excellent oral and written communications skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a cross-functional team.
- 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.