SIRO Clinpharm Private Limited is Hiring Statistical Programmer/ Senior Statistical Programmer

Statistical Programmer/ Senior Statistical Programmer
Looking for Immediate to 30 days' notice period.

For an associate with at least 2-8 years of experience for Statistical programmer position and 8+ years for senior programmer position. Incumbent must have strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. They should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time.

Key asks:

Ability to handle programming activities independently
Core and solid ADaM and TFL experience, eSub will be an added value
Strong SAS experience, any added experience of R will be good
Therapeutic area experience – vaccines, I&I, oncology, biomarkers and PROs

SDTM/ADAM Model and IG

Thorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG’s and related guidelines. Hands on experience in implementing SDTM/ADAM concepts across TA’s and various phases of clinical trains. Good understanding on previous versions on SDTM/ADAM guidelines

Study Reporting

Suggest creative solution approach for various business requirements to solve complex SDTM/ADaM Mapping and Programming problems (e.g. creates modular reusable code, develops standard code or utilities, and designs interconnected programs. Review and author documents related to deliverables (User Guide, CDARS Mapping Specification, OCF, Test Plans, SAS Logs and Programs). Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan etc. Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA’s.

SAS Programming

Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies; review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SASand other advanced SAS components. Mentor and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.

Controlled Terminology

Good understanding of code list and value list concepts. Expertise in managing NCI codelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaM lineage concepts

Other CDISC IGs

Exposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADaM.

Hands on exposure in managing few of these activities

Developing Mapping Specs

Hands on experience in developing mapping specs for SDTM/ADaM. Desirable to have hands on experience in developing mapping specs for a TA or global level SDTM/ADaM mappings. Senior Statistical Programmer is responsible for review of developed SDTM/ADaM mapping specifications

SDTM/ADaM Dataset Programming

Hands on experience in generating SDTM/ADaM datasets using SAS programming or other tool-based approach.

SDTM/ADaM Compliance & Define

Hands on experience generating define.xml files, experience in performing SDTM/ADaM compliance checking using P21 or other compliance checks.

Validation

Implement QA and QC validation in accordance with Departmental SOP’s for deliverables including:

Formal study reports
Data review
Presentations
Adhoc-requests

Along with this the candidate must have good understanding of

Exposure to software development or global macro development process
Exposure in developing user specifications, developing global macros, unit testing
Experience in handling development and maintenance projects
Change Management and Version control process
Clinical guidelines understanding like ICH-GCP, SDTM/ADAM IGs etc.
Client management, communication, project management and other soft skills
Good team player

Share your CV on shailee.kadia@siroclinpharm.com