statistician岗位职责

RESPONSIBILITY:


1. 1、Use SAS to generate reports,descriptive
statistics/tables/listings/figures


2. 2、 Build/new linear/logistic regression models based on the
performance of the data.


3. 3、 Other clinical data analysis work





REQUIRED
COMPETENCE:


1. 1、Majin statistics, mathematics


2. 2、Statistics background: Solid statistical knowledge, such as
mean/SD, regression, multivariate analysis, etc.


3. 3、 SAS Programming skills is preferred.


4. 4、Good verbal, writing communication skills in English.


5. 5、Good attitude with high motivation ability to learn new
skills quickly. Able to multi-task prioritize assignments fefficiency.

Location: 上海/北京/大连/广州/杭州/南京/可全国居家办公
Key requirement:
•Have good experience in Oncology field (preferred in hematology).
•Be experienced in coding, very familiar with ADAM SDTM.
•This role will work on global late phase registration trial submissions, we expect the candidate can efficiently QC a large number of outputs with high quality.
•Minimum 5 years working experience with masters in Biostatistics, fPHD exp. can be at least 3 years.
•Fluent in English.
Job Overview
Prepare analysis plans write detailed specifications fanalysis files, tables, listings figures. Interpret analyses write statistical sections of study reports. Provide training, guidance mentorship to lower level new staff.
Essential Functions
● Production of High-Quality Deliverables: Completes reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), feach task undertaken. Checks programming logs fcleanliness correct processing of data. Inputs Data Issues log follows issues to appropriate resolution.
● Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead supervisto deliver on time, with high quality within budget. Build maintain effective customer relationships, driving statistical discussions, providing support and/guidance fstatistical activities. Demonstrates promotes efficient communication. If in lead role, runs meetings, documenting where necessary following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting.
● Data Management: Assist in reviewing advising data management staff on database design, validation checks critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock unblinding process with appropriate supervision.
● Statistical Analysis Plan (SAP) Shells: Authors performs quality control review (QC) of SAPs shells. Make best use of resources expertise within theganization (e.g. Libraries, templates consultants fcomplex statistical methods). May authQC complex SAPs, under supervision if needed.
● Datasets: Writes maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations assignment.
● Tables, Listings Figures (TLFs): Writes programming specifications fstatistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output fformat content, questions specification as needed. Ensures consistency across items produced.
● Timelines: Plans documents timelines, forecasts resource needs, suggests work may be out of scope.
● Financials: Shares accountability (with resource managers) fthe financial success of assigned studies. Accountable fcontrolling costs maximizing revenue recognition. Responsible fsharing budget expectations with the team. Raises concerns to manager if new work rework appears to be out of scope. Understands scope of work has an awareness of contract budget assumptions.
● Knowledge Sharing: Helps train staff regarding operational items. Mentors junistaff. Supports colleagues provides motivation as needed.
● Risk Management: Identifies risks to project delivery and/quality spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need fstudy level escalations.
● Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes takes proactive approach to gain efficiencies in work across protocols.
● Study Start up: Assist with protocol development, sample size calculation, protocol case report form (CRF) review.
● Protocol: Authors performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources expertise within theganization (e.g. Libraries, templates consultants fcomplex statistical methods).
● Proposals: May be able to review comment on proposals/budgets at a study level. May contribute to request fproposals (RFP). May be expected to present at bid defenses.
● Clinical Study Report (CSR): Reviews drafts CSR statistical report.
● Customer: On occasion, may serve as primary point of contact fcustomer. May also consult on operational topics with clients.
● Lock Unblinding Process: Handles the database lock unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/reduce perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician.
● Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.
Qualifications
● Bachelors Degree Biostatistics related field 1 - 3 years relevant experience Req
● Masters Degree Biostatistics related field 1-3 years relevant experience Req
● Ph.D. Biostatistics related field Req
● Typically requires 1-3 years of prirelevant experience, equivalent combination of education, training experience.
● Requires intermediate level knowledge of principles, theories, concepts of a job area, typically obtained through advanced education combined with experience.
● Excellent writtenal communication skills including grammatical/technical writing skills.
● Excellent attention accuracy with details.
● In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
● Strong individual initiative.
● Strongganizing skills.
● Strong working knowledge of SAS computing package.
● Familiarity with other relevant statistical computing packages such as StatXact.
● Strong commitment to quality.
● Ability to effectively manage multiple tasks projects.
● Ability to provide accept direction of lead team members.
● Ability to solve moderately complex problems.
● Ability to establish maintain effective working relationships with coworkers, managers clients.
● Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).

Applying advanced statistical methods to project work.
Ensuring scientific integrity in the application of statistical methodology to clinical trials.
Participate as senistatistician on majprojects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, preparing integrated clinical statistical reports.
Perform statistical team lead role on single studies.
Develop statistical methods sections of protocols review case report forms (CRFs).
Prepare analysis plans write specifications fanalysis files, tables, figures.
Communicate with clients regarding study protocol statistical analysis issues as they arise.
Communicate with study team members regarding study execution as it relates to timelines, data quality, interpretation of results.
Interpret analyses write statistical sections of study reports.
Conduct independent research teaches courses in statistical methodology.
Bachelors Degree Biostatistics with 7+ years experience Req Masters Degree Biostatistics with 5+ years experience Ph.D. Biostatistics with 2+ years experience
Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials.
In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) International Conference on Harmonization (ICH) guidelines.
Strong working knowledge of SAS.
Excellent writtenal communication skills with good interpersonal skills.
Excellent problem solving skills.