Manager, Statistical Programming

PTC Therapeutics, Inc.•Warren Township, NJ

5d•$134,000 - $160,000

About The Position

The Manager, Statistical Programming performs programming activities for clinical development programs and associated clinical studies, either directly or through oversight of Contract Research Organizations (CROs). The role participates in developing and reviewing statistical programming standard operating procedures and processes, as well as implementing biostatistics computing systems and application development as appropriate. The incumbent works cross-functionally with internal departments and external resources on statistical programming issues and supports adherence to relevant regulatory requirements and company SOPs. The position contributes to statistical programming for assigned studies and programs and ensures timely statistical analyses of clinical data in accordance with protocols and Statistical Analysis Plans. It develops statistical programs and produces outputs used to create integrated scientific reports of clinical trial results. The Manager represents Biostatistics at study team meetings, helps identify statistical issues and solutions, and serves as a statistical programming resource to development teams. The role also supports CRO evaluation and oversight, reviews study documentation and analysis materials, creates or reviews derived dataset specifications and analysis datasets, and may develop SOPs and training guidelines. Other tasks may be assigned by management.

Requirements

Bachelor’s degree in a quantitative sciences discipline, such as Statistics, Mathematics, or Computer Science.
At least 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO, or related environment.
Demonstrated and applied SAS programming skills, including Base SAS, SAS/Stat, SAS/Graph, SAS macros, and ODS.
Good understanding of database systems.
Working knowledge of R.
Experience with Clinical Data Interchange Standards Consortium (CDISC).
Knowledge of clinical data analysis and reporting processes as they relate to drug development.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast-paced, matrixed team environment with internal and external team members.
Analytical thinking, strong problem-solving skills, and ability to adapt to changing priorities and deadlines.
Excellent planning, organization, and time-management skills, including the ability to support and prioritize multiple projects.

Nice To Haves

Master’s degree in a quantitative discipline, such as Statistics, Mathematics, or Computer Science.
Experience working with CROs.
Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.

Responsibilities

Contribute to statistical programming activities for assigned clinical development studies and programs.
Ensure timely statistical analyses of clinical data according to protocols and Statistical Analysis Plans, directly or through CRO oversight.
Develop statistical programs and produce programmed outputs used to create integrated scientific reports for clinical trial results.
Represent the Biostatistics function at study team meetings, contribute to identifying statistical issues and solutions, and serve as a statistical programming resource to development teams.
Participate in the assessment, selection, and evaluation of CROs.
Participate in reviewing Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs, and TLG shells.
Work with CROs and vendor staff to ensure statistical analyses and outputs are accurate and consistent with agreed deliverables, and to characterize and resolve data-analysis issues.
Create or review derived dataset specifications and related analysis datasets.
Develop SOPs and training guidelines related to statistical programming, as appropriate.
Perform other tasks and assignments as needed and specified by management.