Senior Statistical Programmer

4 weeks ago

hyderabad, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Job Qualifications

Ability to fill Statistical Programming Lead role on projects.

Input into and negotiate statistical programming timelines.

Ensure that timelines are adhered to Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.

Monitor project resourcing, project budgets, and identify changes in scope.

Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

Review statistical analysis plans and mock-shells.

Review database set-up specifications.

Interact with sponsors and internal stakeholders with regard to statistical programming issues.

Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Excellent Analytical Skills

Proficiency in SAS.

Extensive knowledge and understanding of the programming and reporting process.

Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.

Ability to learn new systems and function in an evolving technical environment.

Strong project management skills.

Strong organizational skills, ability to manage competing priorities, and flexibility to change

Experience:

Candidates must have minimum of 5+ years of statistical programming in clinical/pharma domain 

Strong programming and analytical skills using SAS software Good knowledge and understanding of CDISC SDTM, ADaM and Define.xml standards & TLF’s

Proven knowledge of regulatory guidance documents, Proven understanding of clinical trials, fundamentals of clinical research, GCP. 

Strong communication (verbal and written) & interpersonal skills Good team player, self-disciplined & self-motivated with ability to learn faster.

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