Principal Biostatistician

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development

Working under the direction of the Principal Programmer, the
**senior statistical programmer** conducts programming activities for a trial, early phase project, indication, or publication activities.
- Lead at least one study team in terms of providing technical and domain-related guidance.
- May require to lead and manage a team of 2-4 members
- Ability to work on data migration from legacy datasets to standards such as **CDISC** or any other client-specific standard.
- Read and understand the program specifications document.
- Prepare SAS analysis datasets, tables, listings, and figures as per specifications.
- Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
- Validate and transform datasets as per client assignment specifications.
- Validate tables, listings, and figures as per client assignment specifications.
- Coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
- Contribute to the organization’s recruitment process by identifying needs and required skill set of resources and conducting interviews to hire appropriate resources.
- Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable

**Qualifications and Experience**:

- Bachelors or Masters's degree in Computer Science, Statistics, or related health science field with 5 plus years of SAS programming experience with clinical trial data.
- CDISC experience is required.
- Well conversant with regulatory requirements and drug development process.
- Good understanding of the Clinical trial domain and good SAS programming skills
- Ability to work independently.

**Inputs from client**:

- Develops and applies knowledge and understanding of emerging statistical methodologies/new research (Bayesian Analyses, Estimand and Missing Data analyses, Adaptive and Group Sequential Designs, Generalized Linear model etc. )
- Utilises sources of data and information (internal/external) and applies statistical concepts to explore and recommend optimal designs (Could be beneficial to have not urgent requirement)
- Influences statistical strategy through authoring analysis plans, (will be beneficial if also have experience authoring sections of key documents (e.g. protocols)) and presentation material
- Identifies opportunities to improve statistical robustness and rigour within projects
- Performs appropriate analysis and interpretation and uses a wide range of statistical approaches and/or applicable software to explore options
- Effectively explains technical concepts to non-statisticians
- Anticipates problems within study or project, proactively uses own expertise and/or seeks input from others, to recommend solutions and influence appropriate change
- Good knowledge of all GxP, ICH requirements
- Independently prepares and communicates conclusions/recommendations and able to adapt appropriately based on audience and feedback

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Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.