Hi

Hope you are doing well

I am Smith, working as a recruiter with Infotree Service Inc.

I am currently working on “*Clinical SAS programmer*” position with
*Medtronic*

I will appreciate your response at the earliest, as the managers tend to
move fast!

 *NOTE  :* *SEND RESUMES WITH THESE DETAILS , Profiles with all mandatory
details would be processed with TOP Priority*





*Name (First & Last)*



*Contact No.*



*Email ID *



*Current Location*



*Willing to Relocate if need*



*Work Visa Status*, *Expiry Date*



*Availability * How soon can you join?*



*Reason for change*





*Are you fine with drug and background check?*





*Skype ID*





*Last 4 Digit SSN No.*



*DOB(Day, Month)*



*Higher Education, Year of Completion *





*Job Title*

*Clinical SAS programmer*

*Project Location*

*Woodcliff Lake, NJ*

*Duration*

*12-36 months /Contract*

 *MOI * *:  * *Telephonic + skype*

*Skills*

*12 months – 3 years assignment*

*ONSITE ONLY – Woodcliff Lake, NJ location*




*Biostat/ SAS programmer Oncology PCU Main duties/responsibilities: *1.
Providing statistical programming and validation support for clinical study
reports, overseeing programming activities by external vendors (e.g., CROs)
when necessary and coordinating programming activities among the study
programmers to achieve timely progress in the following areas: analysis
datasets, statistical tables, figures, listings, Integrated Summaries of
Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB,
progress reports, electronic submissions and other internal and external
requests (e.g., publications). Accessing and converting data to SAS from
Database management system and PC file formats (e.g., MS Excel, text
files). Working with external vendors in order to develop or monitor the
content and structure of SAS data sets.
2. *SDTM and ADaM* technical knowledge are preferred. In addition,
knowledge of agency requirements including ICH, FDA, and other guidances
are beneficial. Knowledge of current FDA submission process (Define.xml,
etc.) is strongly recommended. Developing and maintaining SOPs, SWPs and
other related technical documents, providing input to the Database and CRF
Development. Providing input in developing statistical analysis plans,
producing specifications of analysis datasets, validation plans, and other
related documents. Good understanding with different phases of clinical
trials, protocols, and CRF designs.
3. Maintaining standards for programming activities (SDTM, ADaM, directory
structure, etc.), and guiding/coaching Statistical programmers.
4. Working independently as well as in teams to accomplish tasks and goals
defined by supervisor. Attending required training and meetings and
bringing in new ideas to improve the programming process.
* Responsibilities weighting may change significantly based on the
incumbent and their assigned areas of responsibility.





* Qualifications and education required: • Minimum of Bachelor’s degree in
Statistics, Computer Science, Mathematics, or a related science discipline.
Masters preferred. Experience required: *• Minimum 3 years’ experience in *SAS
programming for phase I-IV clinical trials* in a pharmaceutical/CRO
environment. 6+ years’ experience preferred.
• Some project experience in a *pharmaceutical/CRO programming* environment
or demonstrated significant leadership of SAS programming activities in a
clinical pharmaceutical/CRO environment.


* Skills and aptitude required: *• Experience using *SAS-Base, MACRO, STAT,
GRAPH, ACCESS, MS Office*. Knowledge of *SDTM and ADaM* standards.
• Proven experience with *UNIX and Windows* operating systems.
• Understanding of the *software development life cycle*.
• Understanding of *FDA guidelines*.
• Good organization, time management and attention to detail skills needed
to work in a stressful environment under tight deadlines while maintaining
focus on details and quality.
• Applies good judgment and demonstrates initiative to resolve issues.
• Strong verbal, written and interpersonal communication skills needed to
work effectively in a team environment, managing that team as required

* DOMESTIC SCHOOLS PREFERRED. PHARMA INDUSTRY NOT CRO. STABLE WORK HISTORY*



Thanks & Regards



Smith,

Sr. Technical Recruiter

Infotree Service Inc.

215 Ann Arbor Rd.

Suite 304

Plymouth, MI 48170

734-446-7070

Fax- 734-345-4247

sm...@infotreeservice.com

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