Principal Statistical Programmer - Pharmaceutical

Job Location : Hyderabad or Mumbai

Experience : 8-11 Years

Company : Big Pharmaceutical Company

CTC : Best in the Industry

Job Description :

We advanced a breath of early programs in our pipeline that addresses significant unmet needs and are looking for passionate and enthusiastic Statistical Programmers with expertise in SDTMs, ADaMs & TFLs, and experience in Regulatory Submissions. As a part of the Statistical Programming unit, you will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions. An excellent opportunity to work end-to-end programming from CRF collections through Regulatory submission, you will have an exciting opportunity to learn new technologies (like R) and endorse Statistical Programming as a key contributor in driving the #GO-Digital vision of the company.

Your responsibilities include, but are not limited to :

- Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in the company's Global Drug Development.

- Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.

- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).

- Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.

- Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.

- Provide and implement statistical programming solutions; ensure knowledge sharing.

- In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.

- Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.

- Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.

- Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.

- Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance

- As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

Minimum requirements :

- BA/BS/MS equivalent experience in mathematics, statistics, computer science, or health sciences/related field with Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry

- Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.

- Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications

- Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).

- Good communications and negotiation skills, ability to work well with others globally.

NOTE : We are only considering applications from LGBT+ candidates (LGBT stands for Lesbian, Gay, Bisexual, Transgender, Intersex, Asexual)