Company Description

MakroCare | A MakroGroupCompany | www.MakroCare.com

MakroCare is an ExpertStrategic Development and Commercialization Global Partner for thePharmaceutical, Biotechnology and Medical Device industries. Our Experience,Programs and Processes bring a New Dimension to Development Strategy,Regulatory/Risk Planning & Management, Clinical Research,Medical/Scientific Support and Emerging Region Expansion.

MakroCare is Certified ISO9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical DeviceClinical Investigations)

Senior SAS Programmer

Job Responsibilities:

• Responsible fordesigning, developing, validating and documenting SAS programs to generate datalistings for data review, Safety Tables, Efficacy, create raw datasets and analysis datasets, analyzedata; generate summary tables, figures and listings.

• Maintainup-to-date knowledge of programming software (e.g. SAS) as well as industryrequirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functionalmeetings and trainings

• Responsible forassisting statisticians in the development and review of Statistical Analysisplans and programming specifications 

• Responsible forassisting data management with implementing protocols and support of annotatedCase Report Forms (CRFs), database creation, coding configuration, edit checkprocedures.

• Review the eCRF,data structures and data review activities. Comply with company, department andindustry standards (e.g. CDISC) and processes, Efficacy, Safety Tables create / support the review ofprogramming specifications as part of the analysis plans

• Responsible forassisting data management in development and programming of edit specifications.

• Possesses andmaintains a broad overall knowledge in the field of clinical programming andclinical data management by reading related literature, self-training,attending training classes, attending professional meetings, etc.

• Responsible forquality control and audit readiness of all assigned statistical programmingdeliverables as well as accuracy and reliability of statistical analysisresults.

   

  Qualifications:

   

• 4 years Degreepreferred (B tech in Computer Science with Clinical SAS) or BSc -Statistics or MSc Statistics or MCA (With Clinical SAS).

• Minimum 3 – 6 years of experience within CRO / Biopharma industry.

• The ability todeal effectively with sponsors and internal customers at all levels.

• Excellentcommunication and interpersonal skills, both written and spoken.

• Proficiency inMicrosoft Office Suite and (Word, Excel, and PowerPoint), emails communications.