Associate Manager, Statistical Programming at PTC Therapeutics, Inc. in SOUTH PLAINFIELD, New Jersey

Job Description:

Job Description Summary:

The Associate Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies by working directly with a lead programmer. . Participates in the development of new (and review of existing) statistical programming Standard Operating Procedures (SOPs) and processes. This individual may also participate in biostatistics computing systems implementations and application development.

The incumbent works cross-functionally with internal departments and external resources on statistical programming related issues.

The Associate Manager, Statistical Programming supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

• Contributes to the statistical programming activities for assigned clinical development studies and programs.


• Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans by working with the lead programmer to 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. Contributes to the identification of statistical issues. May collaborate with other members of the statistical programming team to identify solutions. Acts as a statistical/programming resource to the development teams.


• Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells.


• As appropriate, interacts with CROs involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables; works with lead programmer to characterize and resolve issues related to data analysis.


• Assists in creating/reviewing derived dataset specifications and the related analysis datasets.


• Assists in developing SOPs and training guidelines related to statistical programming.


• Performs other tasks and assignments as needed and specified by management. 

Qualifications:

• Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 3 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.

* Special knowledge or skills needed and/or licenses or certificates required.

• 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) knowledge and 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 semi 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. 


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*Special knowledge or skills and/or licenses or certificates preferred.

• Master’s degree in a quantitative discipline (e.g., Statistics, Mathematics, Computer Science).


• Experience working with CROs.

* Travel requirements: 0 – 10%

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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