Please note that the requirements specified in this posting are the basic qualifications required for the Senior Statistical Programmer 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 program-level statistical programming expertise by:
- Designing and executing analysis deliverables to meet the requirements of clinical studies.
- Managing and enforcing standards for derived datasets and analysis outputs to maximize global data integratability.
- Directing the work of external vendors providing statistical programming services to achieve quality and timely, cost-effective study deliverables.
Qualifications EDUCATION, EXPERIENCE AND SKILLS:
- Represent the statistical programming function in support of assigned clinical studies and programs
- Define and manage derived data set and reporting standards using respective TGRD or Takeda Global standards.
- Independently develop, execute, and maintain SASÒ computer programs, including macro programs, according to Statistical Analysis Plans (SAPs), cross-study analysis and data specifications, or analysis requests to:
- Produce statistical analysis output (tables, listings and graphs) to support generation of critical (flash) clinical study results, cross-study results for investigator brochures, regulatory submissions, or ad-hoc and exploratory analyses involving descriptive and simple inferential statistics.
- Perform data manipulations, including creation of derived data sets, related to the production of the statistical output.
- Verify (QC) study and cross-study analysis results or derived data sets produced by another TGRD statistical programmer, statistician, or an external vendor.
- Identify vendor requirements and participate in the evaluation/selection of Analytical Sciences vendors. Provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical programming vendor deliverables.
- Define and manage transfers of all externally produced analysis data and outputs.
- Archive statistical outputs and related documentation according to TGRD standards.
- Anticipate and communicate resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
- Contribute to increasing efficiency of the Statistical Programming function through development of programming utilities, data and output standards, and improvements to the statistical computing environment. Support implementation of such utilities, standards and process improvements.
- Comply with all applicable regulatory requirements and Takeda standards and procedures.
- BS in Statistics, Computer Science, or other related field with minimum 5 years SAS programming experience in the pharmaceutical/CRO industry; or MS in Computer Science, Statistics, or other related field with minimum 4 years SAS programming experience in the pharmaceutical/CRO industry.
- Advanced knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, good knowledge of common procedures in SAS/STAT.
- Good knowledge of general programming and computing principles, experience with Windows NT and UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise in office software (Microsoft Office).
- Good understanding of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
- Working knowledge of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data presentation practices.
- Good knowledge of data management processes, including EDC processes, documents and data flow in clinical trials.
- Basic knowledge of drug development process.
- Good knowledge of FDA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions.
- General project management skills.
- Good oral and written communications skills.
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.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 12 months ago