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Senior Manager, Statistical Programming Lead

4 weeks ago

Warren, United States PTC Therapeutics Full time
Job Summary:

The Senior Manager, Statistical Programming will lead the statistical programming activities for assigned clinical development studies and programs. This role ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; either directly or through CRO oversight develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.

Key Responsibilities:

Leads the statistical programming activities for assigned clinical development studies and programs.
Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; either directly or through CRO oversight develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.
Participates in study team meetings as a representative of the Biostatistics function. Communicates statistical issues and acts as a statistical/programming resource to the development teams.
Participates in the assessment, selection and evaluation of CROs.
Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells.

Requirements:

Master's degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 6 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.
Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems.
Working knowledge of R
Clinical Data Interchange Standards Consortium (CDISC) experience
Knowledge of clinical data analysis and reporting process as it relates to drug development.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Experience working with CROs.
Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.

Travel Requirements:

0 - 10%