Associate Manager - Biostatistician - Pharma

We are hiring Biostatistician at Associate Manager level with a Pharma company.

Scope (inc. Knowledge & Expertise):

- Develop or coordinate the development of statistical analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.

- Perform quality checks, consistency reviews, statistical reviews of the datasets and TFLs.

- Advise to data management staff on database design, validation checks and critical data.

- Perform protocol development, sample size calculation, protocol and CRF review.

- Give inputs to clinical study reports.

- Provide advanced technical expertise along to internal and external Customers and provide solutions to project team for complex studies.

- Act as lead biostatistician for complex studies or group of studies.

- Provide training and guidance to lower level and new staff.

- Performs senior technical review and quality assurance of biostatistics- work products (e.g. Protocols, SAPs, TLFs etc.).

- Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for single studies.

- Review RFPs and prepare proposal text and may attend bid defence meetings.

- Manage customer relationships.

- May hold line management and/or project management responsibilities, coordinates the work of junior staff, manage resources and priorities.

Competencies:

- Excellent SAS programming skills.

- Knowledge of Windows application.

- Strong oral and written communication skills (including the ability to communicate statistical concepts and information to non-statisticians).

- Knowledge of SDTM and ADaM.

- Knowledge of pharmacokinetic data

- Knowledge of electronic submissions.

- Effectively handle multiple tasks and projects.

- Effectively handle team of biostatistician/biostatistical programmers.