Please note that the requirements specified in this posting are the basic qualifications required for the Principal Statistician position; however, job title will be dependent on the candidate's level of experience in those requirements.
The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:
- Independently designing, analyzing and interpreting clinical 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.
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 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.
- Generally requires PhD in statistics or biostatistics with at least 5 years of relevant experience or MS in statistics or biostatistics with at least 7 years of relevant experience. For statisticians with exceptional talent who have demonstrated core capabilities of a Principal Statistician, 3 years of pharmaceutical industry experiences with a PhD in statistics or biostatistics may be considered.
- Experience with advanced study design or 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 OfficeÒ products).
- Excellent oral and written communications skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a cross-functional team.
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.
- 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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