Statistical Programmer Ii

3 months ago

Chennai Tamil Nadu, India Allucent Full time

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for Statistical Programmer II to join our A-team (hybrid*). As a Statistical Programmer II (SP2) you will be supporting the programming of clinical data analysis activities of Allucent. This position is able to support multiple studies, and programs simple to moderate datasets and outputs using SAS®, while beginning to control and monitor specific activities within the project team.

**In this role your key tasks will include**:

- Supports programming of clinical data analyses.
- Create and execute SAS® programs according to project specifications for simple outputs including, but not limited to, data listings.
- Implements statistical analysis plans.
- Understand and comply with all industry-relevant regulatory requirements.
- Employ standardized programs where applicable.
- Validate work of other programmer(s).
- Ensure the maintenance of programming documentation (e.g. description of programs and validation).
- Interacts with statisticians, data management personnel, and project leaders.
- Analyzes and evaluates clinical data, recognizes inconsistencies and initiates resolution of data problems.
- Create and execute SAS® programs according to project specifications for mapped datasets, including SDTM.
- Support projects and execute statistical programming activities according to timelines and milestones promptly without sacrificing quality.
- Generate aCRF, Define XML and other study documents.
- Familiar with Pinnacle 21, managing delivery QC checklists, large study batching, checking logs and other project management processes necessary to lead a study.
- Familiar with CDISC standards and writing SDTM specs for studies with simple complexity.
- Create and/or review SDTM and/or mapped data specifications of simple complexity.
- Actively participate in staff learning & development within the company.
- Ability to provide mentoring to junior staff.
- Understands and completes all SOPs within the Quality Management System on time.
- Assure good communication and professionalism in relationships with (future) clients.
- Contribute and take part in client evaluations, visits and bid defences.

**Requirements**:
**To be successful you should possess**:
Statistics, mathematics, life science, healthcare and/or business degree.

Good analytical skills.

Minimum 2-5 years of relevant work experience.

Minimum 2-5 years of experience in drug development and/or clinical research.

Ability to simplify complex issues into understandable concepts.

GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements.

Strong written and verbal communication skills including a good command of the English language.

Advanced knowledge of SAS /Base, especially macros, arrays, formats and ODS.

Good knowledge of SAS®.

Representative, outgoing and client-focused.

Ability to work in a fast-paced challenging environment of a growing company.

Familiarity with basic statistical principles to interact with biostatisticians.

**Benefits**

**Benefits of working at Allucent include**:

- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

**Disclaimers**:

- Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

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