Manager, Statistical Programming

3 weeks ago

Bengaluru, India Lifelancer Full time
OVERVIEWThe Manager, Statistical Programming is operationally responsible to ensure the direction, planning and execution of the work of the statistical programming team. The Manager, Statistical Programming provides project leadership and programming support for clinical studies. The Manager, Statistical Programming provides guidance in implementing and executing the programming and project standards plus provide hands-on expertise in programming SDTM and ADaM datasets to support various analyses and TLG Programming.KEY TASKS RESPONSIBILITIESDetermine resourcing needs per project

load, deadline requirements and resource utilizationCreate or review and approve programming

plans at study and project levelProvide input on key study-related

documents produced by other functions (e.g. CRFs, Data Management Plans,

SAPs, etc.)Responsible for developing and

maintaining programming and validation specifications for TLGs as per

requirements provided by the BiostatisticianCreate and maintain SAS programs to

produce outputs to support the analysis and reporting of clinical trialsAssist Biostatisticians by suggesting

algorithms to address novel analysis requestsDevelop analysis datasets for trial level

reporting and integrated safety and efficacy activitiesProgram and QC data listings, summaries

and Graphs as defined in SAPDevelop re-usable utility macros to build

a macro library to support programming tables, listing and graphs for all

phases of clinical trial reportingCreate submission ready SDTM and ADaM

datasets following standard industry processesPerforms peer review of all SAS

Programmers deliverablesServe as Subject Matter Expert for

Statistical deliverables and lead task forces to develop complex,

technical solutions for projects or business needsCollaborate with the project team and

other Professional Services Managers to ensure the deliverables are

completed on time with high qualityDevelops and maintains good working

relationships with internal cross functional teams and ClientsDevelops, revises, and maintains Standard

Operating Procedures and Work Instructions. Assists in the training of

Standard Operating Procedures and Work Instructions.Maintain all project documentation as

required by SOP and ProcessesEnsure compliance with eClinical

Solutions and industry quality standards, guidelines, and proceduresMay serve as Lead Statistical Programmer

on projects when neededOther duties as assignedCANDIDATE PROFILEEducation ExperienceBachelor of Science / Master of Science

preferably in Statistics, health-related field, computer science or

equivalent.Minimum 10 years of experience in

Pharmaceutical/Biotechnology industry or equivalent IT consulting role.Professional SkillsStrong experience in preparations for NDA

filingsStrong knowledge of ICH/GCP guidelines,

21 CFR Part 11 and clinical trial methodologiesKnowledge of coding dictionaries (WHO,

COSTART, ICD-9, MedDRA)Knowledge of CDISC related data models

like SDTM, and ADAM.Experience of working on multiple

clinical protocols at the same time.Excellent verbal and written

communication skillsDetail oriented, ability to multitask

with strong prioritization, planning and organization skillsExcellent team playerTechnical SkillsExperience of extracting, manipulating,

merging, summarizing, analyzing and presenting data using SAS proceduresStrong experience of base SAS

programming, Proc SQL, macro programming, ODS and various SAS modules:

SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a

must.Experience with reporting environments

and reporting tools related to SAS programming in pharmaceutical industry;

proc report, proc summary and proc tabulate.Strong experience in SAS programming in

various phases of clinical trial.Experience in pooled data analysis and

programming.Strong experience in efficacy reporting

with regards to development of analysis sets and treating missing values.Experience in working with relational

databases and performance tuning of SAS programmingPlease use the below link for job application and quicker response.

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