Statistical Programmer III
Location
Bangalore | India
Job description
Principal Duties & Responsibilities
- Perform, plan, co-ordinate and implement the following for complex studies: (i) the SAS programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, listings, and graphs and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues.
- Directly communicate with client statisticians and client clinical team members to ensure appropriate understanding of requirements and project timelines.
- Developing DMC Statistical Analysis Plans that are consistent with the protocol and case report forms
- Provide advanced technical expertise in conjunction with internal and external clients
- Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
- Provide training and mentoring to junior team members and other DMC Statistical Center staff.
- Create, maintain, and train staff members on the standard operating proceeds for the independent statistical center
- Oversee and audit work of the other DMC Statistical Center staff.
- Assist in Department and Company projects as they relate to Biostatistical Services.
- Provide coverage within the team and other teams as needed.
- Other duties as assigned.
Job Requirements Education
- Bachelor's degree required in computer science, mathematics, statistics or related fields.
- Masters degree preferred in computer science, mathematics, statistics or related fields
Experience - Minimum of 4+ years of recent experience in Statistical Programming, in SAS environment, in pharmaceutical or medical devices industry.
Knowledge, Skills, Abilities - Must have expertise in SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
- Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
- Must have excellent knowledge of CDISC standards (SDTM and ADaM)
- Must have excellent communication and presentation skills, in English, working with North American and European based pharmaceutical companies.
- Thorough understanding of relational database components and theory.
- Excellent application development skills.
- Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
- Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
- Good verbal and written communication skills.
- Ability to work on multiple projects, plan, organize and prioritize activities.
- Ability to communicate effectively verbally and in writing.
- Excellent interpersonal skills to work effectively with others and provide high levels of customer service.
- Ability to follow instructions and work independently as required; plan, organize, schedule and complete work within competing deadlines and priorities.
- Ability to adapt to changes in office technology, equipment, and/or processes.
- Demonstrated consistency and dependability in attendance, quantity and quality of work.
- Exhibit an advanced knowledge and understanding of regulatory requirements and applications.
- Perform tasks in a consistent and superior manner in terms of volume and efficiency.
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