What are the responsibilities and job description for the Senior Biostatistician II position at Vertex Pharmaceuticals Inc (US)?
Job Description General Summary: The Senior Biostatistician II will perform scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with guidance and mentoring on new and complex issues. The incumbent will complete assigned work in a resourceful manner and create alternative approaches to achieve desired results. The incumbent will develop a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. This position is Boston based with a hybrid schedule of 3 days per week in the office and 2 days per week remote. Key Duties and Responsibilities: Within assigned area, designs, develops and executes the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational studies, or real world data (RWD) investigations, including related areas/activities. Participates in regular Study Execution Team (SET) team meetings as the functional representative. Works under supervision to author study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells, and presentation to Statistical Review Forum (SRF). Plans and conducts Cross-functional Data Review (xFDR) , Key Results Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results. Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality. Provides input into programming specifications and review. Develops statistical section of protocols, including sample size estimates and randomization plan. Contributes to clinical study reports (CSRs) and related processes. May author or co-author methodological or study-related publications and posters. Implements design and analysis methods at the study level and participates in SRF discussions of studies assigned to others. Contributes to departmental working group efforts on various technical and operational issues. Seeks guidance and mentoring on new and complex issues Completes assigned work in a resourceful manner and creates alternative approaches to achieve desired results if needed. Develops a basic knowledge of related disciplines with a drug developer mindset. Knowledge and Skills: Competence with SAS and R statistical software Demonstrated understanding of statistical methods used in drug development Ability to show critical thinking with logical problem-solving Excellent written and verbal communication skills Excels in a team environment Collaborates well with non-statisticians Education and Experience: Ph. D. or master's degree in Statistics or Biostatistics. Typically requires 3 years of experience for those with a master's degree or the equivalent combination of education and experience. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune’s Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. If you have signed up for Job Alerts, please be aware that Job Alert Matches are currently not working. During this time, please check our careers site regularly for all open opportunities. We apologize for this systems issue and hope for it to be resolved soon.