Create SAS programs to generate / validate SDTM datasets as per the
study specifications and support adhoc requests if required.
- To review SDTM mapping specifications, CRFs and annotated CRFs
provided by client for SDTM mapping.
- Create and validate, in accordance with SDTM mapping specification and
SOPs from clinical study data by using SAS programs.
- As required, make certain that documents and specifications are
consistent and comply with company standards and/or as specified by the
client or the client SOPs. For any discrepancy noted raise for
clarification.
- Perform additional programming tasks as requested by client within the
timeframes set out in the applicable client SOPs or as specified by client.
- Implement all the changes to SDTM datasets as requested by the client.
- Work collaboratively with SDTM Tech Lead.
- Attend project teleconferences and other Meetings with supervisor as
required.
- Provide daily / weekly status reports to Global Service Delivery Lead
and SDTM Tech Lead including on-time delivery according to schedule,
specification concerns, issues and risks.
- Perform any other related activities assigned by the supervisor and
participate in task forces/initiatives.
- Support colleagues in non-clinical/organizational initiatives and
provide inputs as required at all meetings and discussions.
- Assist/mentor other programmers whenever required.
- Collaborate on estimating work effort with team members.
- Resolve any issues identified by the database programming team member
and escalate where appropriate.
- Ensure database programming team members are trained appropriately and
maintain training records.
- Provide feedback to database programming team members for quality and
efficiency improvement and ensure corrective actions are taken.
- Conduct performance review / assessments of database programming team
members.
'- Masters/Bachelors degree in Statistics/ Biostatistics/ Applied
Mathematics or related technical discipline. - Prior > 7+ years of
pharmaceutical/clinical SAS Programming. This includes 2+ years of
experience in SDTM mapping using SAS. - SAS experience mandatory. UNIX
experience preferred - Good communication skills (Verbal/Written) ;
appropriately communicates with all levels of customers and employees -
Good organizational and time management skills. - Solid analytical and
technical skills. - Self-motivating, able to assume responsibility and
work autonomously - Trained /experienced in SAS/UNIX. - Ability to
interpret complicated mapping instructions and develop valid conditional
logic statements (of the if-then form) - Experience in SAS programming
environment. - Must be able to accurately and concisely document
information and develop systematic and thorough spreadsheets. - Ability
to handle multiple projects with rapidly changing priorities and
deadlines. - Total commitment to quality and attention to detail. -
Contribute to best practices and process improvementsSriram
--
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