Senior Statistical Programmer - Bengaluru, India - Lifelancer

Description

Who are we lookingfor

Qualificationsand Experience

• BS orhigher degree in Biostatistics Mathematics or related fields. Or acombination of education training and work experience
• 59 years of experience as a Statistical Programmer inCROs pharmaceutical companies biotech companies orsimilar
• Knowledge of GCP and ICHGuidelines
• Experience in business developmentactivities supporting sales teams in the preparation of proposalsand bid defenses
• Experience in theimplementation of technologies and process automatization withinCROs pharmaceutical companies biotech companies orsimilar
• Experience in the implementation ofquality systems
• SAS Certified Specialist: BaseProgramming Using SAS
• SAS CertifiedProfessional: Advanced Programming Using SAS
• Strong analytic mindset and logical thinkingcapability
• Computer and arithmetic knowledgeas well as skills to adapt to different computer systems
• Advanced SAS programming and other statisticalsoftware
• Excellent written and oral Englishcommunication skills
• Ability to defineproblems collect data establish facts and draw validconclusions
• Ability to communicate effectivelywith appropriate internal and external contacts
• Ability to work on multiple projects and to manageproject timelines
• Good organizational and timemanagement skills and initiative
• Goodcommunication and presentation skills
• Goodpeopleskills and teamplayer

Yourresponsibilities

• Primarily working with the Data Managers Statisticiansand Clinical Project Managers on ongoing clinical studies to assureresults are consistent with expectations and quality controlprocedures are followed
• Participating in thecreation and review of key statistical documents including but notexclusive to:

1. Case ReportForm
2. Data Specifications
3. Data Transfer Agreements
4. StatisticalAnalysis Plan
5. Tables Listings and FiguresShells
6. CDISC MappingDocumentation

• Liaisingwith Statisticians and Data Management and Biostatistics Managersat regular intervals to discuss progress and any issuesoutstanding
• Liaising with personnel at thesponsor company or their designates with Central Event AdjudicationCommittees Data Safety Monitoring Committees or any other thirdparties involved in statistical programming activities
• Deriving and adapting data for analysis producing patientlistings summary tables figures and patient profiles as part of SASProgramming
• Producing or participating in thevalidation of SDTM Domains based on the provided Specificationsincluding Pinnacle 21 execution producing or reviewing SDTMSpecifications SDTM reviewer guides Define.XML and any otherdocumentation required for SDTM derivation producing orparticipating in the validation of ADaM Datasets based on theprovided Specifications including Pinnacle 21 execution producingor reviewing ADaM Specifications producing ADaM Reviewer guidesDefine.XML and any other documentation required for ADaM derivationas part of CDISC Mapping
• Training otherproject team members to make full and correct use of the companyprocedures and Biostatistics Reporting Environment
• Applying company standards and actively participating inimprovements towards harmonization and standardization acrossprojects
• Participating as necessary in sponsoraudits regulatory authority inspections and other thirdpartymeetings
• Performing necessary administrativefunctions
• Entering and updating data inrelevant CTMS modules

Please use thebelow link for job application and quickerresponse.

RemoteWork :

No