Statistical Programmer

3 weeks ago

Greater Noida, India Lifelancer Full time

JOB DESCRIPTION:

1 Briefdescription of the job

As aClinical Statistical Programmer you provide statistical programmingexpertise to deliver high

quality programs andoutputs for analysis of clinical data. It is your responsibility toprovide high

quality analysis results on time tosupport efficient decisionmaking.

2 Description of tasks andresponsibilities in each field

Develop Analysis Data Model (ADaM) datasets

Develop Tables Figures and Listings / Output and ProgrammingSpecification (TFL/OPS) from the Statistical Analysis Plan (SAP) or a related document

Develop Define.xml andAnalysis Data Reviewers Guide (ADRG) for datasubmission

Program and validate standard ADaMand utility Statistical Analysis Software (SAS) macros or Rfunction/package following good programmingpractices

Act as a statistical programmingrepresentative within cross functional study teams and project subteams and provide statistical support andsolutions

Provide input to internal processimprovements and/or new statistical programmingcapabilities

Maintain current scientific andregulatory knowledge

Bsc. in StatisticsMathematics Informatics or equivalent

At least 8years of experience as a statistical programmer in thepharmaceutical industry

Proficient in English(oral and written)

Excellent programming skillsin SAS (Macro SQL) and R (function package)

Ableto develop validate and maintain programs

Excellent understanding of the standardization and automatizationprocesses

Excellent knowledge of statisticalconcepts and statistics applied to non clinical pre clinical andclinical data

Excellent knowledge of GCP and ICHguidelines

Excellent communication skills ableto build good relationships with internal and externalstakeholders

Team player able to work in amultidisciplinary team

Able to manage drive andmeet delivery timelines

Excellent knowledge ofCDISC standards (ADaMSDTM)

Please use the belowlink for job application and quickerresponse.

RemoteWork :

No

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