Statistical Programming Services

Teamware Solutions; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Teamware Solutions seeks an experienced SAS programmer to generate derived analysis datasets and production tables/listings/figures for clinical submissions. You will validate programming outputs and support project teams with programming strategies and standards.

The role requires deep experience with CDISC data structures, eClinical data, and downstream outputs like ADaM. Strong collaboration skills and familiarity with Pinnacle 21, XML, and MS Office are essential.

Qualifications

• Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 6 years programming experience in the clinical industry recommended.
• Demonstrated proficiency in analytical programming.
• In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases.
• Demonstrated skills in using software tools and applications (e.g., MS Office, XML, Pinnacle 21).
• Ability to handle upstream data flows including eDC, SDTM and downstream outputs such as ADaM and Data Definition Tables.

Responsibilities

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; perform programming validation to ensure quality.
• Provide programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis.
• Support the electronic submission preparation and review.
• Review planning documents to ensure alignment with development objectives and clarity of programming assumptions.

Skills

SAS programming

CDISC standards

Relational databases

Statistical programming

Analytical skills

Team collaboration

Education

Bachelor's degree in statistics or related field

Tools

Pinnacle 21

XML

MS Office

Job description

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
• Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
• Support the electronic submission preparation and review
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities
• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
• Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices
• Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
• Independently leads and / or performs programming assignments with minimal supervision
• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 6 years programming experience in clinical industry recommended.
• Demonstrated proficiency in analytical programming
• Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database.
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
• Have good understanding of regulatory, industry, and technology standards and requirements.
• Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
• Demonstrated ability to work in a team environment with clinical team members.

Preferred Requirements:

• Minimum of 6 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Experience in other software packages (e.g. R)
• Experience with the Linux operating system