Director, Head of Statistical Programming« Back
Job #: 02-278
Job Title: Director, Head of Statistical Programming
Location: Waltham, MA
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.
We offer an outstanding culture focused on:
- Providing a collaborative and energized work environment
- A diverse and multi-disciplinary workforce
- Dedicated and talented people who are passionate about achieving excellence in all they do
- A commitment to the patients we serve
We are seeking a Director, Head of Statistical Programming to join our team and be responsible for all statistical programming activities. This person will support clinical trials, including technical and project leadership overseeing the quality and timely delivery of all statistical programming deliverables for studies or for submissions. This person will ensure the team develops, maintains, validates and runs quality SAS programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. (S)he will promote strong collaboration with Biostatistics to support analyses for regulatory, medical affairs, and market access needs, as well as strong collaborative relationships with Data Management, Safety, and Clinical Pharmacology. This position may also include people management responsibilities for statistical programmers.
This position will report to the Senior Director, Head of Biometrics and be located in the Waltham, MA office.
- Serves as the Head of SAS Programming for all compounds or key NDA related activities
- Effectively manage all members of the SAS programming team, providing guidance, direction, motivation, and professional development
- Efficiently manage CROs to meet timelines and expectation of quality
- Works collaboratively with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines
- Programs for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards
- Programs TLFs for implementation of the statistical analysis plans and for AdHoc analysis in clinical trial of all phases
- Performs programming QC on TLFs
- Tracks clinical trial milestones and works with vendors for statistical reporting deliverables.
- Maintains records for all assigned projects and archiving of trial/project analysis and associated documentation
- Understands and performs in accordance with regulatory standards, and drug development principles
- Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package
- Plans, develops, tests, and documents SAS macros for programming efficiency
- At least 10 years of experience in statistical programming within the Pharmaceutical industry
- Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions
- Demonstrated success in a supervisory role
- Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development
- Ability to define and implement CDISC compliant SDTM and ADaM data and specifications
- Oncology experience is a plus
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.