Tuesday, April 12, 2016

sas resume

Using SAS In UNIX - Stanford University

https://web.stanford.edu/.../Using_SAS_in_Unix.pdf
Stanford University
Jun 30, 2010 - You can execute SAS command files from the UNIX prompt. ..... Users who prefer working in a windows environment should consider using ... TutorialSAS/ASSIST has an excellent built-in tutorial that uses windows and ...


披马甲问个sas consulting company的问题。。  发贴心情 Post By:1/31/2013 8:22:00 PM 


Bausch + Lomb
1.  (1)Tell me about your experience with in the pharmaceutical industry providing support to clinical project and how many years of experience do you have?
I have been working in the pharmaceutical industry for the past 6 years. I recently work in a Pharmaceutical company named Watson Pharmaceuticals Inc, and it has been purchase by Actavis. I worked there for 2 years. I have strong ability to using SAS/base, SAS/macro and proc sql to generate datasets, tables, figures, and listings to support statistical analysis. I am familiar with the proc function especially the statistical proc function like proc ttest, proc compare, proc univariate, proc freq, proc npar1 way, proc corr, proc anova, proc glm,  proc lifetest,  proc phreg for survival analysis.
I used to developed sas programs to generate dataset and tables including Demographics, Disposition, adverse event, vital signs, laboratories, and accordance with SAP.  Besides I produce statistical reports helping with statistician and data manger. I also doing some validation jobs to make sure the consistency of information presented.
I am engaged in this field for many years because I have passion to work in this field I can utilize my statistical knowledge and SAS skills to collaborate with different professional people to deal with clinical trial problems. One of my strong points is to meet the deadlines. I always do well and get the job done effectively before the deadline. Besides I also have good sprit of teamwork.

 
(2). What are you doing in your last project?
The project I respond for is randomized phase III trial. It is studying Effect of Ferrlecit Versus Oral Iron on Iron Deficient Chronic Kidney Disease Patients Receiving Erythropoietin agents. This study compares the effect of Ferrlecit to ferrous sulfate in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents.
I am in charge of generating datasets, tables, figures, and listings to support the statistical analysis, generate SDTM domains. Using SAS macros clean data, validate data, analyze report and. Perform quality control for SAS programs.

 
3. How long would it take you to create a demographics table from scratch? Once you were done creating your table how would you check it for accuracy?
Most company has their own sas macro-based reporting systems, this it because usually the task associated with repetitive. Using the macro-based reporting systems, it takes 20-30mins to do some basic modification. If no existing macros can be applied, it takes around 2-3 hours to generate a table from scratch.
My first step is to check the log window to see if there is any error or warning message. After fixing the errors, I usually use proc contents to see if the variables name, type, label and formats is right according the spec. I also use proc sort to see how many cells it has to compare with other colleague’s result. I also re-calculated descriptive and standard statistics by creating another SAS program with simple procedures such as proc univariate and proc freq, and compared outputs with the table results.

 
4. What SAS procedures would you use to generate summary statistics for Age?  Height?  Gender? Once you were done creating your table how would you check it for accuracy?
I will use proc means or proc univariate to generate summary for numeric variables and I will use proc freq to do data summary statistics for the categorical data , for example as gender. 
5.Have you ever done QC on datasets or tables/listings on studies you’ve worked on in the past? Describe the QC process you have used in the past.
I will do independent programming and generate my own data sets. In this process, I will use proc content to see the variable type, variable format, variable label and variable length. Make sure it is same as the spec demand. Besides, I also use the proc sort to see the number of data. Finally I will use proc compare to compare the dataset I derived with my colleague’s results. If they are 100% match it could be use as QC, if not we will figure out the mistakes.

 
List Proc compare syntax:
Proc compare
Base=
Compare=
Run;

6. Give me 2 examples of each data type (safety and efficacy) from studies you’ve worked on in the past?
Demo- demographic dataset includes general variables such as subject ID, age, age-group, sex, A/S/E and race. It is an essential baseline characteristics domain.
Usually the CDISC classify the interventions class, event class, finding class, other special class for example: demographic.

 
Lab laboratory dataset, it usually contains variables like the laboratory test, the data and time, the laboratory test result and units, baseline lab value, changes from baseline lab value, the percent change from baseline lab value, flag for records to be used in analysis, abnormally high or low, study day.

In my study, the dataset has the variable to analysis the lab test like the iron contain percentage test, the test percentage of haemoglobin, the baseline lab value of haemoglobin concentration, the Baseline Serum Ferritin Concentration, the abnormally high or low of hemoglobin.


 
Safety:
AE:
I have been involved in a phase 4 to do the compare study of effect of ferrlecit versus oral iron on iron deficiency and Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents. To test whether there is any untoward medical occurrence in a patient or clinical investigation subject, we make the dataset to get many kinds of variable to get the information. For example, the Full name of preferred term, the adverse event name, the relationship to study drug, the severity of adverse event, the severity of adverse event, the action taken, the date of onset of AE, the date of resolution of AE, the start date of AE, duration of AE, the adverse event flag, any serious adverse event flag, the TEAE flag.


 
Efficacy:
KM: it is Kaplan-Meier analytic file, this file contains variables to be used in the Kaplan-Meier survival statistics. The variables it contains for example: the day of onset treatment, the date of failure, the data is right censored, and the duration of treatment.

 
The study:
This study compares the effect of Ferrlecit? (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and 在iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit? and Aranesp?.
Anemia, Iron-Deficiency
Kidney Failure, Chronic
Drug: Sodium Ferric Gluconate complex in sucrose
Drug: Ferrous sulfate tablets
Phase 4

Study Type:
Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:
A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit? vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy

Endpoints for the study:
The endpoint or event assessments capture what the clinical trial was designed to study.
The co-primary endpoints:
·         Baseline Hemoglobin Concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
·         Change in Hemoglobin (Hgb) [ Time Frame: Baseline to 10 weeks ] [ Designated as safety issue: No ]
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Secondary efficacy endpoints:
·         Baseline Serum Ferritin Concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
·         Change in Serum Ferritin [ Time Frame: Baseline to 10 weeks ] [ Designated as safety issue: No ]
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.

Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy

This study has been completed.
Sponsor:
Watson Pharmaceuticals
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224068
First received: September 13, 2005
Last updated: February 29, 2012
Last verified: February 2012
Purpose
This study evaluates the safety and efficacy of Ferrlecit? (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.

Anemia
Drug: Sodium ferric gluconate, ferrous sulfate, standard of care
Phase 4

Study Type:
Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:
A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit? in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment

Resource links provided by NLM:

 
MedlinePlus related topics: Anemia Cancer Iron

 

[此贴子已经被作者于2013/8/16 21:49:37编辑过]
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8. Have you been involved with project resourcing of multiple programmers, assessing timelines for project completion, and review of project team member’s programming code? Also, have you been involved with statisticians or other functional areas, i.e. DMP, medical writing, medical monitors, ets.?
Yes, of course. When we get a project we get the data which has been managed from the data manager, they have a group of people to deal with the CRF, database design and setup, data entry, data cleaning, data coding, and they give the data to statistic programmer and when we give the data, it is clean and well-coded. And if there are some problem to enter the data to sas, for example if the data has problem about format and it didn’t be divide by a proper set, or some problem with the Marco system which is been setup before, we can discuss the problem with the data management. On the other hand, if there are some problem of the spec or the statistical data analysis function, maybe some statistician using some new test we will asking about their opinion to do the SAS analysis.

 
9. How do you assess a peers program for accuracy?
If produce the datasets, tables listings, I will use proc compare to compare it with my colleagues, but first of all I will generate my own datasets, table and listings. I also use the proc contents to get the numbers of the datasets generates to compare with them. Otherwise, I will use proc univeriate and proc freq to get the data summary result to compare with the result from the template one in SAPs.

 
10. How many projects are you responsible for at one time? Describe your ability to handle multiple tasks and prioritize?
In the Watson pharmaceutical Inc, sometimes I lead a team. We always have some multiple project in one group, so we always leads different projects and do the multiple jobs. For example, last month I did a study project about compares the effect of Ferrlecit to ferrous sulfate in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents. I am the leader of this study. I hold meetings to assign task for our group of people, explain the SAPs, and provide sas output resource to medical writer , assist the statistician to review the output. Besides that, I am also the group member in other project study team. I will follow leader’s guide to do the regular job. I always arrange my own team’s job first and quick assign the task, and meet the deadline for other groups. If I have enough time I will help my group member to finish coding quickly.

 
11. Have you been faced with a deadline that seemed insurmountable and how did you handle the programming resourcing for this project? Have you make the decision to prioritize study completion? If so, why did you have to make this decision?
I have ability to do a good job to meet the deadline usually. Sometimes I always have few projects in hands, and I arrange time to deal with it. If I do the regular job like making datasets tables, Besides the job is huge and takes time, I will make a schedule to finish it part by part, I insist follow the schedule and finally I will finished it before the deadline. If time is limit beside I also do an important part in a study I will finish it first, and squeeze time to finish other scheduled tasks.
12. Aside from SAS, which other scientific/statistical programming languages do you have working knowledge of and how much experience/number of years?
I use spss do the statistical project from undergraduate school, it’s above 3 years. I have a published paper. I do the data analysis using spss and sas. I learn R in graduate school and do some project in school using R.
13. Do you ever do SAS programming in UNIX environment? How long?
Yes, I using in stony brook for one year experience. I am familiar with the command.
14. Do you have experience in the systems development? Are you aware of the SDLC(System Development Lifecycle)? How have you used it in the course of your development?
NO.
15.what has your exposure been in developing SOPs or Guidelines for statistical programming?
I work in the Watson pharmaceutical company. Our Manager always have monthly meeting. We discuss on developing new documents about trial programmers’ responsibilities for several weeks. Our manager was very open-mind, we have opportunity to discussed how to do the QC job for table making, or the deadline issue and task assignment issue.
16. How would you rate your knowledge of clinical trial methodologies? Which phases of clinical trial have you worked with the most/least(phase I, II, III,IV or even pre-clinical)
I will rate myself 7. Recently, the study I am in are phase IV. I also do the phase II, III study for the safety and efficacy analysis. Usually I worked in I, II, III to making datasets, deriving demographic, AE lab result datasets.

 
17. What statistical procedures are you most familiar with to analyze data?
I have Strong statistics knowledge background including Statistic Inference, Categorical Data(probit, logistic, baseline, clog, log-log regression), Design of experiment, Statistical Modeling and Regression (mixed model, GLM, multilevel model, non-parametric model, ANOVA) Statistic Test(t-test, Chi-square, npar1way, kaplan-Meier, fisher, Kruskal-Wallis, Wilcoxon, F-test, Tukey-test, McNemar-test, Likelihood Ratio-test, life-test and so on), Statistical Estimate( MLE, OLS, GMM, Moment Generating function) Dealing with Missing Data(imputation, mean method), Survival Analysis associated with Professional in SAS/STAT such as proc ttest, proc univariate, proc freq, proc npar1way, proc corr, proc anova, proc glm, proc logistics

 
18. What SAS functions are you most familiar with?
Sum max min std mean---compute simple descriptive statistics
Sqrt abs upcase lowcase
Int—return an integer of an argument
Put --- read the source with a specified informat and convert it to a character variable
Input---read the source with a specified informat and convert it to a numerical variable
Scan---return a given word from a character string using default and specified delimiters
Substr---extract a string from an argument or replace character value contents
Compress---remove specific characters
Trim---remove trailing blanks from a character string
Length---return the length of an argument
Floor---return the largest integer that is less than or equal to the argument
Ceil---return the smallest integer that is greater than or equal to the argument
Today ( ) with a null set of parentheses --- return today’s date from the system clock

 
19. How extensive have you used MACROs within your code? And why do you use MACROs?
Many task such as making datasets, tables, and listings are repetitive. Then I will use Macros to get a systems. when I make some similar datasets, tables I will easily use the MACROs’ system to make a little change in my program and change the variable value and to get the result.

 
20. Why are you seeking other opportunities?
Because my contract will be end in June, I’d like to get another opportunity to work in a pharmaceutical company like yours. It is large and has good environment. Besides I like the place and want to relocate there.

 
21. Any Experience in Data Manager.
22. Any experience in Health Outcome or Health Care/Claim
23. Write an appreciation letter


 
Questions:
What is the auto.exe in the beginning of all the sas program code?
What is SDLC ?
Where to find the Safety and efficacy variables classification?
What is Full name of preferred term, full name of the lower level term, the full name of the higher group level?

 
What is system organ class?
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Career Overview

·           Seeking a senior SAS programmer position in pharmaceutical/CRO industries

 
 Qualifications
  • Nearly 6 years  SAS programming experience in the pharmaceutical Company and CRO
  • Master Degree in Applied Mathematics and Statistics with solid statistical and pharmaceutical knowledge background
  • Strong knowledge of clinical trial process including Phase Pre-clinic/I/II/III/IV, FDA, ICH and CDISC guidelines
  • Familiar with SAP, Protocol, CRF, SOP, clinical trial process
  • Developing and maintaining macros for company system
  • Expertise in manipulate SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACROS, SAS/SQL and SAS/ODS
  • Good skills at SAS data steps and Procedures such as proc print, proc means, proc contents, proc compare, proc sql, set, merge, proc sort, proc tabulate, proc report, proc freq and proc transpose
  • Strong ability data analysis of clinical data, especially in debugging SAS/MACROS to access, extract, modify, merge and to generate statistical outputs
  • Excellent team worker with good communicate skills
  • Good at complete multi-tasks before deadline under time pressure
  • Expertise in statistical analysis, statistic modeling, bio-statistics and data collection and analysis
  • Strong programming skills with other statistical software including R/SPSS/Minitab
  • Professional in SAS/STAT such as proc ttest, proc univariate, proc freq, proc npar1way, proc corr, proc anova, proc glm, proc logistics
  • Strong statistics knowledge background
         Statistic Inference Theory
 Design of experiment
Categorical Data: probit, logistic, baseline, clog, log-log regression
Statistical Modeling and Regression: mixed model, GLM, multilevel model, non-parametric model, ANOVA
Statistic Test: T-test, Chi-Square, npar1 way, Kruskal-Wallis, Fisher Exact test, F-test, Tukey-test, McNemar-test, Likelihood Ratio test, life-test
Statistical Estimate: MLE, OLS, GMM, Moment Generating Function
Dealing with Missing Data: Imputation, Mean method
Survival Analysis

 
Work History
 Celgene                                                        Summit NJ 07901                                                    May 2011 ~ current
Sr. SAS Programmer
·         Reviewing CRFs, edit check specifications
·         Acting as a team leader for a group of SAS programmer, analysis SAP
·         Developed SAS programs to produce statistical tables, graphics representations, and data listings in accordance with the requirement.
·         Offer statistical programming support to supplemental or exploratory analyses for regulatory agencies
·          Fulfill the requests of any internal and external ad-hoc
·         Providing guidance and mentoring to peer and junior programmers in programming methodologies
·         Ensure consistency and adherence to standards within their therapeutic area.
·         Perform quality control for SAS programs and other study documents
·         Provide programming support for the preparation of integrated reports, submissions and NDA submission activities
·         Serve as the primary project team representative, delegating work as appropriate
·         Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
·         Contribute to the creation of naming conventions and standards for the programming environment.
·         Providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
·         Developed SAS programs to produce analysis datasets into SDTM according SDTM mapping
·         Validated SDTM according to mapping specification

 

Forest Laboratories Inc.                             Jersey City NJ 07931                                        April 2009 ~ April 2011
Sr. SAS Programmer
·         Planning, organizing, and managing statistical programming activities in support of multiple projects or one entire therapeutic area
·         Providing support for creating and maintaining programs to analyze and report trial data
·         Ensuring that all statistical programs adhere to department standards
·         Reviewing, maintaining and approving study documents per standard procedures
·         Providing quality control for study documents, programs and outputs of statistical programs
·         Effectively contribute to department study teams
·         Derived datasets including Demographics, Disposition, Adverse Event, Vital Signs, Laboratories, Time to Event, Medical History, Created table/listing/Figures for both the safety and efficacy analysis of clinical trial
·         Assess the feasibility of the analysis plan and timelines associated with analysis plan
·         Using SAS macros cleaning data, validation, analysis and report generation, routing processing
·         Produce statistical reports with statistician, data manager
·         Cross check statistical and data tables, listings, and figures generated both internally and externally to validate consistency of information presented, validate results from independent programmers, and ensure consistency of formatting.
·         Provide filling and regulatory programming support for FDA submission, doing E-submission to FDA, such as Transport Files(xpt) and define


 
  Vertex                                                                  Branchburg  NJ                                                 Oct 2007~ Feb2009                                                                   
  Statistical Programmer
·         Provide statistical programming support and validation and help set specifications of analysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials.
·         Provide input into planning documents such as protocol, validation plan, and report analysis plan.
·         Provide outputs for clinical study reports, integrated summaries and electronic submissions.
·         Help respond to health authority inquiries for submitted dossiers.
·         Data cleaning, validation, analysis and report generation, routing processing, test using SAS macros
·         Develop and review SAS programs and output for the management and reporting of clinical trial data
·         Establish and maintain sound working relationship and effective communications within biostatistics and statistical reporting and clinical research.
·         Applied SAS, SAS/macro to provide statistical reports,  presented results in tabular and graphic formats
·         Demonstrated ability to work independently on a project

 
Education & Certification
Stony Brook University – Stony Brook, New York             Major: MS in Applied Mathematics and Statistics
  • Courses included:  Analytical Methods for Applied Mathematics and Statistics, Probability, Categorical Data, Regression Theory, Statistical Computing Using R and SAS, Data Analysis, Design of Experiments, Application of SAS and R and Statistical Package for the Social Sciences

 
Beijing University of Technology – Beijing, China                                                       Major: BS in Statistics
  • Courses included:    Probability Principle ,  The Principle of Statistics,  Application of Mathematical Statistics, Calculate,  Data Analysis, SPSS, Application of Excel in Statistics, Demography, Survey Design, Statistical Analysis  in Enterprise

 
SAS Certifications
  • SAS Certified Base Programmer for SAS 9 Credential
  • SAS Certified Advanced Programmer for SAS 9 Credential

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