Center For Biomedical Research Of The Population Council Work Values

Daily Duties at Center For Biomedical Research Of The Population Council:

1. Biostatistical Work.  Work with other Biostatisticians in designing data presentations, developing statistical plans of research studies, definition of patient populations, measurement of outcome variables and hypotheses developments.  Provide input on sections of clinical protocols, end point specifications, study logistics, sample size determination, randomization plans and statistical analysis.  Review statistical analysis plan (SAP) including Table shells and convert SAP into programming specifications for the creation of Analysis Data Model (ADAM) datasets.  SAS coding to create ADAM datasets to be used for the analysis of the Clinic trial and for NDA submissions.  Conduct efficacy and safety analysis including demographic, efficacy, adverse event, laboratory and other clinical data collected from patients.  Primary production of Tables of high statistical contents e.g. P-value, Point estimates, confidence intervals , time to event (survival) curves, event or response rates etc.  Generated Plasma Concentration Graphs and calculated Pharmacokinetic parameters such AUC∞ AUCt1-t2, Tmax Cmax etc.  Responsible for the development of program specifications and programming of the Tables, Listing and Graph (TLG) from Table Shells at the various phases of the Clinical Trial to be used for the reporting of the Clinical Trial Study Report (CSR). 2. SAS Programming Work. • Create, test and maintain SAS programs for clinical studies according to company standard procedures. • Convert and Transfer data files from UNIX based database (iDataFax) to SAS data files. • Create new variables and deriving new datasets from raw data sources. Creating and merging of large datasets by multiple keys. Transposition of vertical data into horizontal form and vice versa. • Provide summaries of intent to treat population of demography, baseline symptoms and signs, compliance with treatment, compliance with visit schedule etc. • Create tables and listings using SAS procedures such as Proc Report, Proc Tabulate, Proc SQL etc. • Conduct safety summaries of all Adverse events, Vital signs, Physical Examinations, Gynecological examinations and Laboratory examinations. • Review and edit SAS codes from other SAS programmers. • Utilized SAS Statistical procedures such as Proc Means, Proc Univariate, Ttest, Proc Corr, Proc Reg, Proc Lifetest, Proc Phreg, Proc Anova, Lsmeans procedure, Proc Mixed, Proc Genmod, Proc Gplot, and Gchart etc. • Other SAS procedures used includes Proc report, Proc freq, Proc SQL, Proc append, Proc Transpose, merge.Cport etc. • Provided ongoing mentoring within Statistical Programming group to ensure thorough knowledge of the processes used and the ongoing technical development. 3. Data Management Work. • Maintained Clinical Trials Application and Database (DataFax) for a Health Research Studies. • Review database specifications and Case Report Forms design (CRF) and its annotations, identify errors and inconsistencies in the CRF, data review, resolution of data discrepancies, data coding and data entry and other data cleaning activities. • Designed clinical database structure for the capture and storage of laboratory data. • Perform SAS coding to retrieve laboratory data from the main lab into the Clinical database and its subsequent preparation for statistical analysis. • Extensively used Dynamic Data Exchange (DDE) for importing data from Excel Sheet in to SAS database. • Designed SOP for the Laboratory data, Quality Control (QC) issuance and report generation. • Edit check design and specifications as well as edit check programming and validation routines... • Generated sites reports for the Principal investigators of the multicenter studies. • Initiated an in-house development of study reports that include tables, listing and figures for NDA submissions. • Hands on Experience With Clinical Trials 1. Created analysis datasets from specifications on this protocol: Phase III Study of the Efficacy and Safety of a regimen in preventing HIV Seroconversion in Women. 2. Created analysis datasets specifications based on SAP and produced Tables, Listings and Graph (TLG) for Clinical trial protocols such as:  A multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics, cycle control and safety of a regimen.  A Randomized, Cross-Over Study comparing the effect of one regimen against another.  A randomized, open-label study comparing the effect of contraceptive regimen to an oral regimen on hepatic factors including coagulation factors.  A multicenter open-label study on the efficacy, cycle control and safety of a regimen.  Pharmacokinetics of a regimen after application of a another regimen in post menopausal women.  Study of Ovulation Inhibition and menstrual patterns in women .

What they like about Center For Biomedical Research Of The Population Council:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

SAS, ADAM, Statistics, relational database, Tables, Listing, Graph, TLF, SDTM, Data analyst, Statistical analyst, SAS Drug Development (SDD), Clinical trial, SPSS

Skills

• Relational database design, programming and administration, • Statistical software : SAS, SPSS, Minitab, Stata., • SAS Tools: SAS V9.3, SAS/BASE, SAS ACCESS, SAS CONNECT, SAS SQL. SAS MACROS, SAS GRAPH, SAS STAT, SAS ODS, SAS Drug Development (SDD)., TLF production expertise, • Clinical coding using MeDRA Dictionary., • Unix based Clinical Trials application and database (iDataFax), the prima, • 4GL Language: Visual basic 6.0, VBA, Delphi, Oracle SQL, Crystal reports., • Decision Support System Tools : Business Objects, • Microsoft ACCESS developer and Microsoft office suite (Access, Word, Excel, PowerPoint)., • Client / Server application dev. using Visual Basic as front end and ACCESS and SQL Server as backends

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