Statistical Programmer-ii

2 weeks ago

Remote, India Parexel Full time

As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.

You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.

Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: Minimal
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Team player
- Tech-Savvy
- Communicator
- Proactive
- Detail-oriented
- Analytical

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Development**: Opportunity to learn and grow through a performance and development goal-setting program.
- **Variety**: Opportunity to work on a wide range of therapeutic areas and medical devices.

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with mínimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

**Job Qualifications**
- Deliver best value and high quality service.
- Check own work in an ongoing way to ensure first-time quality.
- Use efficient programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
- Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
- Provide relevant training and mentorship to staff and project teams as appropriate.
- Excellent analytical skills.
- Proficiency in SAS.
- Knowledge and understanding of the programming and reporting process.
- Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
- Ability to learn new systems and function in an evolving technical environment.
- Ability to manage competing priorities and flexibility to change.
- Attention to detail.
- Ability to successfully work as part of a global team.
- Work effectively in a quality-focused environment.
- Effective time management in order to meet daily metrics or team objectives.
- Show commitment to and perform consistently high-quality work.
- Business/operational skills that include customer focus, commitment to quality management, and problem solving.
- Competent in written and oral English.

**Experience**:

- Strong programming and analytical skills using SAS software
- Good knowledge and understanding of CDISC SDTM, ADaM and Define.xml standards & TLF’s
- Proven knowledge of regulatory guidance documents
- Proven understanding of clinical trials, fundamentals of clinical research, GCP
- Strong communication (verbal and written) & interpersonal skills
- Good team player, self-disciplined & self-motivated with ability to learn faster

**Education**:

- A Masters in statistics, mathematics, or another relevant discipline. Or B.Sc., Life Science Graduates/ Statistics Graduate/ SAS certified preferable.

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