Associate Director, Statistical Programming

Job Description Summary:

The Associate Director, Statistical Programming provides technical leadership and operational oversight for the statistical programming activities required to support multiple clinical development programs, the associated clinical studies and regulatory submissions. This role is also responsible for guiding the development and review of statistical programming Standard Operating Procedures (SOPs) and processes. He/She may also participate in biostatistics computing systems implementations and application development as appropriate.

He/She may manage direct reports.

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

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

Job Description:

• Leads the statistical programming project team (including Clinical Research Organization (CRO) oversight as necessary) in support of clinical development programs in the assigned therapeutic areas.
• Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; 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
• 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 vendor staff to characterize and resolve issues related to data analysis.
• Creates/Reviews derived dataset specifications and the related analysis datasets.
• Manages internal contractors and junior programmers and provides mentorship as needed.
• Develops SOPs and training guidelines related to statistical programming.
• Performs other tasks and assignments as needed and specified by management. 

Qualifications:

* Minimum level of education and years of relevant work experience.

• Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 7 years of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment OR a Bachelor’s degree in  a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 9 years of progressively responsible 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.
• Expertise in the implementation of Clinical Data Interchange Standards Consortium (CDISC) standards.
• Applied knowledge of clinical data analysis and reporting processes as related to drug development.
• Proficiency with Microsoft Office.
• 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.

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

• Experience working directly with CROs.
• Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.

* 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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