Principal SAS Programming
Company: Katalyst Healthcares & Life Sciences
Posted on: January 23, 2023
- As a clinical trial lead statistician, familiarize with the
workflow of statistical related process in clinical trials, plan
and complete statistical analysis plan, use SAS programming to
produce TFL outputs; familiarize with and support data collection
and management related statistical tasks in clinical trials,
including completion of case report form CRF, data management plan
DMP, data validation plan DVP, protocol deviation specification
DVP, and data transfer agreement DTA, etc;
- Support protocol writing and review to provide a blueprint for
development of SAP; support protocol amendment, including the
communication of modifications and justifications with regulatory
- To streamline and optimize the working process in the
department as requested, propose actionable suggestions.
- Independently complete various types of statistical jobs,
including sample size calculation, development and implementation
of randomization, development of statistical analysis plan and TFL
mock shell, development of statistical analysis report and clinical
study report, and other statistical related documents with quality
assurance of each document; guide junior statisticians on related
jobs through document review.
- Be responsible for project management in terms of timeline and
budget, execute the plan after alignment with all stakeholders;
organize, coordinate and participate internal and external
communications to ensure the smooth conduct of the project on time
and within budget; participate in project meetings, such as
protocol discussion meeting, data review meeting, statistical
analysis discussions meeting.
- Independently support pre-sale biding activities, including
statistical consultation of clinical trial study design, selection
of statistical analysis methods, prepare bid defense meeting
presentation slides, respond to client's questions to assist
- Follow SOP, ICH-GCP and other applicable regulatory guidelines
in daily work; constantly review and summarize personal work and
ensure the first-time quality.
- Deliver various statistical analysis results with high
standards and quality.
- Perform QC of analysis specifications, derived datasets,
Tables, Listings, Figures (TLFs).
- Familiar with the frequently used clinical trial related laws,
regulations, requirement, guidance of specific therapeutic areas,
statistical analysis and/or programming methods, and share to other
staffs in the department for learning; share knowledge or provide
training with regard to statistics and/or statistical programming
and provide guidance and mentoring to other staffs in the
- Additional responsibilities as needed in the department.
- Master's or PhD degree in mathematics, statistics,
biostatistics or related area or equivalent work experience with
master's degree with 4-6 years of experience with solid
understanding of statistical knowledge.
- Be familiar with clinical biostatistics work and proficient in
SAS programming to produce TLFs.
- Familiarize with different types of interim analysis in
clinical trials, including the reason of conduction, objectives,
process and analysis methods.
- Well experienced in project management and perform various
statistical analysis independently.
- Be familiar with applicable clinical research regulatory
requirements, i.e., Good Clinical Practice (GCP), International
Conference on Harmonization (ICH) guidelines, and various guideline
on clinical trial evaluation and conduction from regulatory
agencies; Be familiar with common statistical analysis concepts and
methods in clinical studies.
- Familiar with the clinical data standards on submission, such
- Good statistical skills and thinking, professional working
attitude detail-oriented, good teamwork and problem-solving
- Excellent written and oral English communication skills
including grammatical/technical writing skills.
- Good leadership skills.
Keywords: Katalyst Healthcares & Life Sciences, Pleasanton , Principal SAS Programming, Other , Pleasanton, California
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