Statistical Programmer - Remote

4w4 weeks ago

Innovaderm Research Inc.

Pune, IN · Full-time · INR 700,000 – INR 1,000,000

About this role

The Statistical Programmer is responsible for developing, maintaining, and validating aCRFs, SDTM and ADaM datasets, and TLFs for DMC meetings, interim analyses, and clinical study reports. They also support data management with cleaning activities and use global SAS macros to improve programming efficiency.

Daily duties include developing specifications and programming SDTMs, ADaMs, and TLFs based on protocols, aCRFs, and statistical analysis plans. The programmer validates these datasets using Pinnacle 21 and collaborates with the lead biostatistician to address any findings appropriately.

The Statistical Programmer works collaboratively within biostatistical study teams and across departments to produce high-quality deliverables on time and within budget. All work conforms to ICH guidelines, pharmaceutical industry standards, regulatory requirements, and Innovaderm’s SOPs and processes.

The role includes participating in internal initiatives to improve efficiency and quality of programming activities, such as developing standard macros and templates. The programmer is expected to stay current with the latest industry and CDISC standards as well as ICH and regulatory guidance.

Requirements

Proficiency in SAS programming for developing SDTM, ADaM datasets, and TLFs.
Knowledge of CDISC standards including SDTM Implementation Guide and ADaM Implementation Guide.
Experience using Pinnacle 21 for validation of SDTM and ADaM datasets.
Understanding of ICH guidelines and pharmaceutical industry standards.
Familiarity with clinical trial data management and data cleaning processes.
Ability to create and maintain annotated Case Report Forms (aCRFs).
Attention to detail and ability to produce high-quality deliverables within timelines.

Responsibilities

Develop, maintain, and validate annotated Case Report Forms (aCRFs) according to protocol, eCRF, and CDISC SDTM IG and CT.
Develop, maintain, and validate specifications and primary or QC statistical programming of SDTMs, ADaMs, and TLFs.
Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
Support data management with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues.
Use global SAS macros to increase efficiency of statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
Participate in internal initiatives to increase efficiency or quality of statistical programming activities, including development or improvement of standard macros, templates, and programming standards.
Develop, maintain, and validate SDTM define.XML/PDF, cSDRG, ADaM define.XML/PDF, and ADRG.
Review statistical programming scope of work and budget at initiation of clinical trials and identify out-of-scope tasks.

Benefits

Remote or hybrid work arrangement based on preference.
Opportunity to contribute to internal initiatives and improve programming standards.
Exposure to regulatory guidelines and CDISC standards.
Work on high-impact clinical trials for data monitoring committees and regulatory submissions.